@pactosigna/mcp-server 0.1.8 → 0.1.9

package/dist/index.js

@@ -21406,6 +21406,1054 @@ var PactoSignaApiClient = class {
 
 // ../schemas/dist/index.js
 var import_gray_matter = __toESM(require_gray_matter(), 1);
+var CAPA_STATUSES = [
+  "open",
+  "investigation",
+  "implementation",
+  "verification",
+  "closed",
+  "cancelled"
+];
+var CAPA_CLASSIFICATIONS = ["corrective", "preventive"];
+var CAPA_PRIORITIES = ["low", "medium", "high", "critical"];
+var CAPA_SOURCE_TYPES = [
+  "nonconformance",
+  "complaint",
+  "audit_finding",
+  "observation",
+  "other"
+];
+var CAPA_ACTION_STATUSES = ["pending", "in_progress", "completed"];
+var COMPLAINT_STATUSES = [
+  "open",
+  "investigating",
+  "resolved",
+  "closed",
+  "cancelled"
+];
+var COMPLAINT_SEVERITIES = ["low", "medium", "high", "critical"];
+var COMPLAINT_CATEGORIES = [
+  "quality",
+  "safety",
+  "performance",
+  "usability",
+  "other"
+];
+var COMPLAINT_SOURCES = ["customer", "internal", "regulatory", "distributor"];
+var NC_STATUSES = [
+  "reported",
+  "investigation",
+  "disposition",
+  "closed",
+  "cancelled"
+];
+var NC_SEVERITIES = ["minor", "major", "critical"];
+var NC_DISPOSITIONS = [
+  "use_as_is",
+  "rework",
+  "scrap",
+  "return_to_supplier",
+  "concession"
+];
+var NC_SOURCE_TYPES = [
+  "product",
+  "process",
+  "supplier",
+  "audit_finding",
+  "complaint",
+  "other"
+];
+var ACTION_STATUSES = ["open", "in_progress", "completed", "cancelled"];
+var ACTION_PRIORITIES = ["low", "medium", "high", "critical"];
+var ACTION_SOURCE_TYPES = [
+  "capa",
+  "nonconformance",
+  "complaint",
+  "management_review",
+  "custom_review",
+  "audit_finding",
+  "quality_objective"
+];
+var OBJECTIVE_TYPES = ["auto", "manual"];
+var OBJECTIVE_STATUSES = ["on_track", "at_risk", "off_target", "not_started"];
+var OBJECTIVE_DIRECTIONS = ["above", "below"];
+var OBJECTIVE_CADENCES = ["monthly", "quarterly", "annual"];
+var AUTO_METRIC_SOURCES = [
+  "capa.avgCycleTimeDays",
+  "capa.overdueCount",
+  "capa.openCount",
+  "nonconformance.avgCycleTimeDays",
+  "nonconformance.overdueCount",
+  "nonconformance.openCount",
+  "complaint.avgCycleTimeDays",
+  "complaint.overdueCount",
+  "complaint.reportableCount",
+  "training.complianceRate",
+  "training.overdueCount",
+  "release.avgCycleTimeDays",
+  "audit.findingsMajor",
+  "audit.findingsMinor"
+];
+var REVIEW_STATUSES = [
+  "scheduled",
+  "draft",
+  "in_progress",
+  "completed",
+  "cancelled"
+];
+var REVIEW_CADENCES = ["monthly", "quarterly", "semi_annual", "annual"];
+var REVIEW_DATA_SOURCES = [
+  "capas",
+  "nonconformances",
+  "complaints",
+  "training",
+  "releases",
+  "audits"
+];
+var CreateQualityReviewRequestSchema = external_exports.object({
+  reviewTypeId: external_exports.string().min(1),
+  title: external_exports.string().min(1).max(200),
+  scheduledDate: external_exports.string().datetime(),
+  reviewPeriod: external_exports.object({
+    from: external_exports.string().datetime(),
+    to: external_exports.string().datetime()
+  })
+});
+var AddDecisionRequestSchema = external_exports.object({
+  description: external_exports.string().min(1).max(2e3),
+  decidedBy: external_exports.string().min(1)
+});
+var AddAttendeeRequestSchema = external_exports.object({
+  memberId: external_exports.string().min(1),
+  name: external_exports.string().min(1),
+  department: external_exports.string().min(1),
+  role: external_exports.string().min(1)
+});
+var UpdateReviewNotesRequestSchema = external_exports.object({
+  notes: external_exports.string().max(1e4)
+});
+var ListQualityReviewsQuerySchema = external_exports.object({
+  reviewTypeId: external_exports.string().optional(),
+  status: external_exports.enum(REVIEW_STATUSES).optional(),
+  page: external_exports.coerce.number().int().positive().default(1),
+  limit: external_exports.coerce.number().int().positive().max(100).default(20)
+});
+var QmsReviewParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1)
+});
+var ReviewIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1),
+  reviewId: external_exports.string().min(1)
+});
+var MonthlyTrendSchema = external_exports.object({
+  month: external_exports.string(),
+  opened: external_exports.number(),
+  closed: external_exports.number()
+});
+var ReviewDataSnapshotSchema = external_exports.object({
+  capas: external_exports.object({
+    total: external_exports.number(),
+    open: external_exports.number(),
+    overdue: external_exports.number(),
+    avgCycleTimeDays: external_exports.number().nullable(),
+    trend: external_exports.array(MonthlyTrendSchema)
+  }).optional(),
+  nonconformances: external_exports.object({
+    total: external_exports.number(),
+    open: external_exports.number(),
+    overdue: external_exports.number(),
+    avgCycleTimeDays: external_exports.number().nullable(),
+    bySeverity: external_exports.record(external_exports.string(), external_exports.number()),
+    trend: external_exports.array(MonthlyTrendSchema)
+  }).optional(),
+  complaints: external_exports.object({
+    total: external_exports.number(),
+    open: external_exports.number(),
+    overdue: external_exports.number(),
+    reportableCount: external_exports.number(),
+    trend: external_exports.array(MonthlyTrendSchema)
+  }).optional(),
+  training: external_exports.object({
+    totalTasks: external_exports.number(),
+    complianceRate: external_exports.number(),
+    overdue: external_exports.number()
+  }).optional(),
+  releases: external_exports.object({
+    total: external_exports.number(),
+    avgCycleTimeDays: external_exports.number().nullable()
+  }).optional(),
+  audits: external_exports.object({
+    totalFindings: external_exports.number(),
+    major: external_exports.number(),
+    minor: external_exports.number(),
+    observations: external_exports.number()
+  }).optional()
+});
+var ReviewObjectiveSnapshotSchema = external_exports.object({
+  objectiveId: external_exports.string(),
+  title: external_exports.string(),
+  target: external_exports.number(),
+  value: external_exports.number().nullable(),
+  status: external_exports.string(),
+  direction: external_exports.string(),
+  unit: external_exports.string()
+});
+var ReviewDecisionSchema = external_exports.object({
+  description: external_exports.string(),
+  decidedBy: external_exports.string()
+});
+var ReviewAttendeeSchema = external_exports.object({
+  memberId: external_exports.string(),
+  name: external_exports.string(),
+  department: external_exports.string(),
+  role: external_exports.string()
+});
+var QualityReviewResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  reviewNumber: external_exports.string(),
+  title: external_exports.string(),
+  reviewTypeId: external_exports.string(),
+  reviewTypeName: external_exports.string(),
+  status: external_exports.enum(REVIEW_STATUSES),
+  scheduledDate: external_exports.string(),
+  conductedDate: external_exports.string().nullable(),
+  reviewPeriod: external_exports.object({
+    from: external_exports.string(),
+    to: external_exports.string()
+  }),
+  ownerDepartment: external_exports.string(),
+  ownerDepartmentRole: external_exports.enum(["manager", "member"]),
+  dataSources: external_exports.array(external_exports.enum(REVIEW_DATA_SOURCES)),
+  attendees: external_exports.array(ReviewAttendeeSchema),
+  dataSnapshot: ReviewDataSnapshotSchema,
+  objectiveSnapshots: external_exports.array(ReviewObjectiveSnapshotSchema),
+  decisions: external_exports.array(ReviewDecisionSchema),
+  notes: external_exports.string().nullable(),
+  completedAt: external_exports.string().nullable(),
+  completedBy: external_exports.string().nullable(),
+  createdAt: external_exports.string(),
+  createdBy: external_exports.string(),
+  updatedAt: external_exports.string()
+});
+var ListQualityReviewsResponseSchema = external_exports.object({
+  items: external_exports.array(QualityReviewResponseSchema),
+  total: external_exports.number(),
+  page: external_exports.number(),
+  limit: external_exports.number(),
+  hasMore: external_exports.boolean()
+});
+var CreateReviewTypeRequestSchema = external_exports.object({
+  name: external_exports.string().min(1).max(200),
+  dataSources: external_exports.array(external_exports.enum(REVIEW_DATA_SOURCES)).min(1),
+  requiredSections: external_exports.array(external_exports.string().min(1)).default([]),
+  ownerDepartment: external_exports.string().min(1),
+  ownerDepartmentRole: external_exports.enum(["manager", "member"]),
+  cadence: external_exports.enum(REVIEW_CADENCES),
+  advanceNotificationDays: external_exports.number().int().min(1).max(30).default(7),
+  includeObjectives: external_exports.boolean().default(false)
+});
+var UpdateReviewTypeRequestSchema = external_exports.object({
+  name: external_exports.string().min(1).max(200).optional(),
+  dataSources: external_exports.array(external_exports.enum(REVIEW_DATA_SOURCES)).min(1).optional(),
+  requiredSections: external_exports.array(external_exports.string().min(1)).optional(),
+  ownerDepartment: external_exports.string().min(1).optional(),
+  ownerDepartmentRole: external_exports.enum(["manager", "member"]).optional(),
+  cadence: external_exports.enum(REVIEW_CADENCES).optional(),
+  advanceNotificationDays: external_exports.number().int().min(1).max(30).optional(),
+  includeObjectives: external_exports.boolean().optional()
+});
+var QmsReviewTypeParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1)
+});
+var ReviewTypeIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1),
+  reviewTypeId: external_exports.string().min(1)
+});
+var ReviewTypeResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  name: external_exports.string(),
+  isBuiltIn: external_exports.boolean(),
+  dataSources: external_exports.array(external_exports.enum(REVIEW_DATA_SOURCES)),
+  requiredSections: external_exports.array(external_exports.string()),
+  ownerDepartment: external_exports.string(),
+  ownerDepartmentRole: external_exports.enum(["manager", "member"]),
+  cadence: external_exports.enum(REVIEW_CADENCES),
+  advanceNotificationDays: external_exports.number(),
+  includeObjectives: external_exports.boolean(),
+  isActive: external_exports.boolean(),
+  createdAt: external_exports.string(),
+  updatedAt: external_exports.string()
+});
+var ListReviewTypesResponseSchema = external_exports.object({
+  items: external_exports.array(ReviewTypeResponseSchema)
+});
+var RISK_DOCUMENT_TYPES = [
+  "software_risk",
+  "usability_risk",
+  "security_risk"
+];
+var HAZARD_DOCUMENT_TYPES = ["haz_soe_software", "haz_soe_security"];
+var ALL_RISK_RELATED_DOCUMENT_TYPES = [
+  ...RISK_DOCUMENT_TYPES,
+  ...HAZARD_DOCUMENT_TYPES,
+  "hazardous_situation",
+  "harm"
+];
+var QMS_DOCUMENT_TYPES = [
+  "sop",
+  "policy",
+  "work_instruction",
+  "supplier",
+  // Internal audit management (ISO 13485 §8.2.2)
+  "audit_schedule",
+  "audit_report",
+  // Management review (ISO 13485 §5.6)
+  "management_review"
+];
+var DEVICE_DOCUMENT_TYPES = [
+  "user_need",
+  "requirement",
+  "architecture",
+  "detailed_design",
+  "test_protocol",
+  "test_report",
+  "usability_risk",
+  "software_risk",
+  "security_risk",
+  "hazardous_situation",
+  "harm",
+  "haz_soe_software",
+  "haz_soe_security",
+  "hazard_category",
+  // Usability engineering (IEC 62366)
+  "usability_plan",
+  "use_specification",
+  "task_analysis",
+  "usability_evaluation",
+  "summative_evaluation",
+  // Risk management (ISO 14971)
+  "risk_management_plan",
+  // Software lifecycle (IEC 62304)
+  "software_development_plan",
+  "software_maintenance_plan",
+  "soup_register",
+  // Problem resolution (IEC 62304 §9)
+  "anomaly",
+  // Cybersecurity (IEC 81001-5-1)
+  "cybersecurity_plan",
+  "sbom",
+  // Clinical (MDR / FDA)
+  "clinical_evaluation_plan",
+  "clinical_evaluation_report",
+  // Post-market surveillance (MDR Art. 83)
+  "post_market_surveillance_plan",
+  "post_market_feedback",
+  // Labeling (MDR Annex I)
+  "labeling",
+  // Product (ISO 13485 §7.3)
+  "product_development_plan",
+  "intended_use",
+  // Release management (IEC 62304 §5.7)
+  "release_plan",
+  // Change management (ISO 13485 §7.3.5)
+  "design_review",
+  "release_notes",
+  // Software test plan (IEC 62304 §5.7)
+  "software_test_plan"
+];
+var DOCUMENT_TYPES = {
+  user_need: "User Need",
+  requirement: "Requirement",
+  architecture: "Architecture",
+  detailed_design: "Detailed Design",
+  test_protocol: "Test Protocol",
+  test_report: "Test Report",
+  sop: "SOP",
+  work_instruction: "Work Instruction",
+  policy: "Policy",
+  usability_risk: "Usability Risk",
+  software_risk: "Software Risk",
+  security_risk: "Security Risk",
+  // Risk document types
+  haz_soe_software: "Hazard (Software)",
+  haz_soe_security: "Hazard (Security)",
+  hazardous_situation: "Hazardous Situation",
+  harm: "Harm",
+  hazard_category: "Hazard Category",
+  // Usability engineering (IEC 62366)
+  usability_plan: "Usability Plan",
+  use_specification: "Use Specification",
+  task_analysis: "Task Analysis",
+  usability_evaluation: "Usability Evaluation",
+  summative_evaluation: "Summative Evaluation",
+  // Risk management (ISO 14971)
+  risk_management_plan: "Risk Management Plan",
+  // Software lifecycle (IEC 62304)
+  software_development_plan: "Software Development Plan",
+  software_maintenance_plan: "Software Maintenance Plan",
+  soup_register: "SOUP Register",
+  // Problem resolution (IEC 62304 §9)
+  anomaly: "Anomaly",
+  // Cybersecurity (IEC 81001-5-1)
+  cybersecurity_plan: "Cybersecurity Plan",
+  sbom: "SBOM",
+  // Clinical (MDR / FDA)
+  clinical_evaluation_plan: "Clinical Evaluation Plan",
+  clinical_evaluation_report: "Clinical Evaluation Report",
+  // Post-market surveillance (MDR Art. 83)
+  post_market_surveillance_plan: "Post-Market Surveillance Plan",
+  post_market_feedback: "Post-Market Feedback",
+  // Labeling (MDR Annex I)
+  labeling: "Labeling",
+  // Product (ISO 13485 §7.3)
+  product_development_plan: "Product Development Plan",
+  intended_use: "Intended Use",
+  // Release management (IEC 62304 §5.7)
+  release_plan: "Release Plan",
+  // Change management (ISO 13485 §7.3.5)
+  design_review: "Design Review",
+  release_notes: "Release Notes",
+  // Supplier management (ISO 13485 §7.4)
+  supplier: "Supplier",
+  // Internal audit management (ISO 13485 §8.2.2)
+  audit_schedule: "Audit Schedule",
+  audit_report: "Audit Report",
+  // Management review (ISO 13485 §5.6)
+  management_review: "Management Review",
+  // Software test plan (IEC 62304 §5.7)
+  software_test_plan: "Software Test Plan"
+};
+var LINK_TYPES = {
+  derives_from: "Derives From",
+  implements: "Implements",
+  verified_by: "Verified By",
+  mitigates: "Mitigates",
+  parent_of: "Parent Of",
+  related_to: "Related To",
+  // New risk link types
+  leads_to: "Leads To",
+  results_in: "Results In",
+  analyzes: "Analyzes"
+};
+var REQUIRED_SECTIONS = {
+  user_need: ["Purpose", "Stakeholder", "User Needs"],
+  architecture: ["Purpose"],
+  release_plan: ["Scope", "Applicable Plans", "Release-Specific Criteria", "Known Anomalies"],
+  design_review: ["Review Scope", "Attendees", "Findings", "Actions", "Conclusion"],
+  release_notes: ["Changes", "Known Issues"],
+  audit_schedule: ["Scope", "Audit Criteria"],
+  audit_report: ["Scope", "Methodology", "Findings", "Conclusion"],
+  management_review: ["Review Inputs", "Review Outputs", "Action Items", "Decisions"],
+  hazard_category: ["Description", "Examples", "Applicable Standards"]
+};
+var MemberPermissionsSchema = external_exports.object({
+  canSign: external_exports.boolean(),
+  canApprove: external_exports.boolean(),
+  canCreateRelease: external_exports.boolean(),
+  canPublishRelease: external_exports.boolean(),
+  canManageMembers: external_exports.boolean(),
+  canViewAuditLog: external_exports.boolean(),
+  canExport: external_exports.boolean()
+});
+var ErrorResponseSchema = external_exports.object({
+  error: external_exports.string(),
+  code: external_exports.string().optional(),
+  details: external_exports.record(external_exports.unknown()).optional()
+});
+var PaginationParamsSchema = external_exports.object({
+  limit: external_exports.coerce.number().min(1).max(100).optional().default(50),
+  offset: external_exports.coerce.number().min(0).optional().default(0)
+});
+var NcStatusSchema = external_exports.enum(NC_STATUSES);
+var NcSeveritySchema = external_exports.enum(NC_SEVERITIES);
+var NcDispositionSchema = external_exports.enum(NC_DISPOSITIONS);
+var NcSourceTypeSchema = external_exports.enum(NC_SOURCE_TYPES);
+var QmsNcParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1)
+});
+var NcIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1),
+  ncId: external_exports.string().min(1)
+});
+var CreateNcRequestSchema = external_exports.object({
+  severity: NcSeveritySchema,
+  sourceType: NcSourceTypeSchema,
+  title: external_exports.string().min(1).max(200),
+  description: external_exports.string().min(1).max(5e3),
+  dueDate: external_exports.string().datetime().optional(),
+  affectedDocumentIds: external_exports.array(external_exports.string().min(1)).default([]),
+  affectedDeviceIds: external_exports.array(external_exports.string().min(1)).default([])
+});
+var UpdateNcRequestSchema = external_exports.object({
+  title: external_exports.string().min(1).max(200).optional(),
+  description: external_exports.string().min(1).max(5e3).optional(),
+  severity: NcSeveritySchema.optional(),
+  investigationDescription: external_exports.string().max(5e3).optional(),
+  affectedDocumentIds: external_exports.array(external_exports.string().min(1)).optional(),
+  affectedDeviceIds: external_exports.array(external_exports.string().min(1)).optional(),
+  dueDate: external_exports.string().datetime().nullable().optional()
+});
+var SetDispositionRequestSchema = external_exports.object({
+  disposition: NcDispositionSchema,
+  justification: external_exports.string().min(1).max(5e3)
+});
+var ApproveConcessionRequestSchema = external_exports.object({
+  signatureId: external_exports.string().min(1)
+});
+var NcListQuerySchema = PaginationParamsSchema.extend({
+  status: NcStatusSchema.optional(),
+  severity: NcSeveritySchema.optional(),
+  sourceType: NcSourceTypeSchema.optional()
+});
+var NcResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  qmsId: external_exports.string(),
+  organizationId: external_exports.string(),
+  ncNumber: external_exports.string(),
+  severity: NcSeveritySchema,
+  sourceType: NcSourceTypeSchema,
+  title: external_exports.string(),
+  description: external_exports.string(),
+  investigationDescription: external_exports.string().optional(),
+  disposition: NcDispositionSchema.optional(),
+  dispositionJustification: external_exports.string().optional(),
+  concessionSignatureId: external_exports.string().optional(),
+  affectedDocumentIds: external_exports.array(external_exports.string()),
+  affectedDeviceIds: external_exports.array(external_exports.string()),
+  linkedCapaId: external_exports.string().optional(),
+  status: NcStatusSchema,
+  createdAt: external_exports.string(),
+  createdBy: external_exports.string(),
+  investigationStartedAt: external_exports.string().optional(),
+  investigationStartedBy: external_exports.string().optional(),
+  dispositionSetAt: external_exports.string().optional(),
+  dispositionSetBy: external_exports.string().optional(),
+  closedAt: external_exports.string().optional(),
+  closedBy: external_exports.string().optional(),
+  cancelledAt: external_exports.string().optional(),
+  cancelledBy: external_exports.string().optional(),
+  dueDate: external_exports.string().optional()
+});
+var NcListResponseSchema = external_exports.object({
+  items: external_exports.array(NcResponseSchema),
+  total: external_exports.number(),
+  limit: external_exports.number(),
+  offset: external_exports.number()
+});
+var AlertRecipientSchema = external_exports.object({
+  department: external_exports.string().min(1),
+  departmentRole: external_exports.enum(["manager", "member"])
+});
+var CreateQualityObjectiveRequestSchema = external_exports.object({
+  title: external_exports.string().min(1).max(200),
+  description: external_exports.string().min(1).max(5e3),
+  type: external_exports.enum(OBJECTIVE_TYPES),
+  metricSource: external_exports.enum(AUTO_METRIC_SOURCES).optional(),
+  unit: external_exports.string().min(1).max(50),
+  target: external_exports.number(),
+  direction: external_exports.enum(OBJECTIVE_DIRECTIONS),
+  warningThreshold: external_exports.number(),
+  ownerDepartment: external_exports.string().min(1),
+  ownerDepartmentRole: external_exports.enum(["manager", "member"]),
+  alertRecipients: external_exports.array(AlertRecipientSchema).default([]),
+  reviewCadence: external_exports.enum(OBJECTIVE_CADENCES),
+  effectiveDate: external_exports.string().datetime(),
+  targetDate: external_exports.string().datetime().optional()
+});
+var UpdateQualityObjectiveRequestSchema = external_exports.object({
+  title: external_exports.string().min(1).max(200).optional(),
+  description: external_exports.string().min(1).max(5e3).optional(),
+  unit: external_exports.string().min(1).max(50).optional(),
+  target: external_exports.number().optional(),
+  direction: external_exports.enum(OBJECTIVE_DIRECTIONS).optional(),
+  warningThreshold: external_exports.number().optional(),
+  ownerDepartment: external_exports.string().min(1).optional(),
+  ownerDepartmentRole: external_exports.enum(["manager", "member"]).optional(),
+  alertRecipients: external_exports.array(AlertRecipientSchema).optional(),
+  reviewCadence: external_exports.enum(OBJECTIVE_CADENCES).optional(),
+  targetDate: external_exports.string().datetime().nullable().optional()
+});
+var RecordObjectiveValueRequestSchema = external_exports.object({
+  value: external_exports.number(),
+  note: external_exports.string().max(1e3).optional()
+});
+var ListQualityObjectivesQuerySchema = external_exports.object({
+  type: external_exports.enum(OBJECTIVE_TYPES).optional(),
+  status: external_exports.enum(OBJECTIVE_STATUSES).optional(),
+  isActive: external_exports.enum(["true", "false"]).transform((v) => v === "true").optional(),
+  page: external_exports.coerce.number().int().positive().default(1),
+  limit: external_exports.coerce.number().int().positive().max(100).default(20)
+});
+var QmsObjectiveParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1)
+});
+var ObjectiveIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1),
+  objectiveId: external_exports.string().min(1)
+});
+var QualityObjectiveSnapshotResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  value: external_exports.number(),
+  status: external_exports.enum(OBJECTIVE_STATUSES),
+  source: external_exports.enum(["auto", "manual", "review"]),
+  reviewId: external_exports.string().nullable(),
+  capturedAt: external_exports.string(),
+  capturedBy: external_exports.string().nullable()
+});
+var QualityObjectiveResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  objectiveNumber: external_exports.string(),
+  title: external_exports.string(),
+  description: external_exports.string(),
+  type: external_exports.enum(OBJECTIVE_TYPES),
+  metricSource: external_exports.enum(AUTO_METRIC_SOURCES).nullable(),
+  unit: external_exports.string(),
+  target: external_exports.number(),
+  direction: external_exports.enum(OBJECTIVE_DIRECTIONS),
+  warningThreshold: external_exports.number(),
+  currentValue: external_exports.number().nullable(),
+  currentValueUpdatedAt: external_exports.string().nullable(),
+  status: external_exports.enum(OBJECTIVE_STATUSES),
+  ownerDepartment: external_exports.string(),
+  ownerDepartmentRole: external_exports.enum(["manager", "member"]),
+  alertRecipients: external_exports.array(
+    external_exports.object({
+      department: external_exports.string(),
+      departmentRole: external_exports.enum(["manager", "member"])
+    })
+  ),
+  reviewCadence: external_exports.enum(OBJECTIVE_CADENCES),
+  effectiveDate: external_exports.string(),
+  targetDate: external_exports.string().nullable(),
+  isActive: external_exports.boolean(),
+  createdAt: external_exports.string(),
+  createdBy: external_exports.string(),
+  updatedAt: external_exports.string(),
+  // Optional: included when fetching detail with snapshots
+  recentSnapshots: external_exports.array(QualityObjectiveSnapshotResponseSchema).optional()
+});
+var ListQualityObjectivesResponseSchema = external_exports.object({
+  items: external_exports.array(QualityObjectiveResponseSchema),
+  total: external_exports.number(),
+  page: external_exports.number(),
+  limit: external_exports.number(),
+  hasMore: external_exports.boolean()
+});
+var ActionSourceSchema = external_exports.object({
+  type: external_exports.enum(ACTION_SOURCE_TYPES),
+  id: external_exports.string().min(1),
+  displayNumber: external_exports.string().optional()
+});
+var CreateActionRequestSchema = external_exports.object({
+  title: external_exports.string().min(1).max(200),
+  description: external_exports.string().min(1).max(5e3),
+  source: ActionSourceSchema,
+  assigneeDepartment: external_exports.string().min(1),
+  assigneeDepartmentRole: external_exports.enum(["manager", "member"]),
+  assigneeId: external_exports.string().optional(),
+  priority: external_exports.enum(ACTION_PRIORITIES),
+  dueDate: external_exports.string().datetime()
+});
+var UpdateActionRequestSchema = external_exports.object({
+  title: external_exports.string().min(1).max(200).optional(),
+  description: external_exports.string().min(1).max(5e3).optional(),
+  assigneeDepartment: external_exports.string().min(1).optional(),
+  assigneeDepartmentRole: external_exports.enum(["manager", "member"]).optional(),
+  assigneeId: external_exports.string().nullable().optional(),
+  priority: external_exports.enum(ACTION_PRIORITIES).optional(),
+  dueDate: external_exports.string().datetime().optional(),
+  notes: external_exports.string().max(5e3).optional()
+});
+var ListActionsQuerySchema = external_exports.object({
+  sourceType: external_exports.enum(ACTION_SOURCE_TYPES).optional(),
+  sourceId: external_exports.string().optional(),
+  status: external_exports.enum(ACTION_STATUSES).optional(),
+  assigneeDepartment: external_exports.string().optional(),
+  priority: external_exports.enum(ACTION_PRIORITIES).optional(),
+  page: external_exports.coerce.number().int().positive().default(1),
+  limit: external_exports.coerce.number().int().positive().max(100).default(20)
+});
+var CompleteActionRequestSchema = external_exports.object({
+  notes: external_exports.string().max(5e3).optional()
+});
+var QmsActionParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1)
+});
+var ActionIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1),
+  actionId: external_exports.string().min(1)
+});
+var ActionResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  actionNumber: external_exports.string(),
+  title: external_exports.string(),
+  description: external_exports.string(),
+  source: external_exports.object({
+    type: external_exports.enum(ACTION_SOURCE_TYPES),
+    id: external_exports.string(),
+    displayNumber: external_exports.string().optional()
+  }),
+  assigneeDepartment: external_exports.string(),
+  assigneeDepartmentRole: external_exports.enum(["manager", "member"]),
+  assigneeId: external_exports.string().nullable(),
+  priority: external_exports.enum(ACTION_PRIORITIES),
+  dueDate: external_exports.string(),
+  status: external_exports.enum(ACTION_STATUSES),
+  isOverdue: external_exports.boolean(),
+  completedAt: external_exports.string().nullable(),
+  completedBy: external_exports.string().nullable(),
+  notes: external_exports.string().nullable(),
+  createdAt: external_exports.string(),
+  createdBy: external_exports.string(),
+  updatedAt: external_exports.string()
+});
+var ListActionsResponseSchema = external_exports.object({
+  items: external_exports.array(ActionResponseSchema),
+  total: external_exports.number(),
+  page: external_exports.number(),
+  limit: external_exports.number(),
+  hasMore: external_exports.boolean()
+});
+var CapaStatusSchema = external_exports.enum(CAPA_STATUSES);
+var CapaClassificationSchema = external_exports.enum(CAPA_CLASSIFICATIONS);
+var CapaPrioritySchema = external_exports.enum(CAPA_PRIORITIES);
+var CapaSourceTypeSchema = external_exports.enum(CAPA_SOURCE_TYPES);
+var CapaActionStatusSchema = external_exports.enum(CAPA_ACTION_STATUSES);
+var QmsCapaParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1)
+});
+var CapaIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1),
+  capaId: external_exports.string().min(1)
+});
+var CapaActionIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1),
+  capaId: external_exports.string().min(1),
+  actionId: external_exports.string().min(1)
+});
+var CreateCapaRequestSchema = external_exports.object({
+  classification: CapaClassificationSchema,
+  priority: CapaPrioritySchema,
+  title: external_exports.string().min(1).max(200),
+  description: external_exports.string().min(1).max(5e3),
+  sourceType: CapaSourceTypeSchema,
+  sourceDescription: external_exports.string().min(1).max(2e3),
+  sourceId: external_exports.string().max(200).optional(),
+  dueDate: external_exports.string().datetime().optional(),
+  affectedDocumentIds: external_exports.array(external_exports.string().min(1)).default([]),
+  affectedDeviceIds: external_exports.array(external_exports.string().min(1)).default([])
+});
+var UpdateCapaRequestSchema = external_exports.object({
+  title: external_exports.string().min(1).max(200).optional(),
+  description: external_exports.string().min(1).max(5e3).optional(),
+  priority: CapaPrioritySchema.optional(),
+  rootCauseDescription: external_exports.string().max(5e3).optional(),
+  verificationDescription: external_exports.string().max(5e3).optional(),
+  affectedDocumentIds: external_exports.array(external_exports.string().min(1)).optional(),
+  affectedDeviceIds: external_exports.array(external_exports.string().min(1)).optional(),
+  dueDate: external_exports.string().datetime().nullable().optional()
+});
+var CloseCapaRequestSchema = external_exports.object({
+  signatureId: external_exports.string().min(1)
+});
+var AddCapaActionRequestSchema = external_exports.object({
+  description: external_exports.string().min(1).max(2e3),
+  assigneeId: external_exports.string().min(1),
+  dueDate: external_exports.string().datetime(),
+  notes: external_exports.string().max(2e3).optional()
+});
+var UpdateCapaActionRequestSchema = external_exports.object({
+  description: external_exports.string().min(1).max(2e3).optional(),
+  assigneeId: external_exports.string().min(1).optional(),
+  dueDate: external_exports.string().datetime().optional(),
+  status: CapaActionStatusSchema.optional(),
+  notes: external_exports.string().max(2e3).optional()
+});
+var CapaListQuerySchema = PaginationParamsSchema.extend({
+  status: CapaStatusSchema.optional(),
+  classification: CapaClassificationSchema.optional(),
+  priority: CapaPrioritySchema.optional()
+});
+var CapaActionResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  description: external_exports.string(),
+  assigneeId: external_exports.string(),
+  assigneeEmail: external_exports.string(),
+  dueDate: external_exports.string(),
+  status: CapaActionStatusSchema,
+  completedAt: external_exports.string().optional(),
+  notes: external_exports.string().optional()
+});
+var CapaResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  qmsId: external_exports.string(),
+  organizationId: external_exports.string(),
+  capaNumber: external_exports.string(),
+  classification: CapaClassificationSchema,
+  priority: CapaPrioritySchema,
+  title: external_exports.string(),
+  description: external_exports.string(),
+  sourceType: CapaSourceTypeSchema,
+  sourceId: external_exports.string().optional(),
+  sourceDescription: external_exports.string(),
+  rootCauseDescription: external_exports.string().optional(),
+  verificationDescription: external_exports.string().optional(),
+  affectedDocumentIds: external_exports.array(external_exports.string()),
+  affectedDeviceIds: external_exports.array(external_exports.string()),
+  actions: external_exports.array(CapaActionResponseSchema),
+  status: CapaStatusSchema,
+  createdAt: external_exports.string(),
+  createdBy: external_exports.string(),
+  investigationStartedAt: external_exports.string().optional(),
+  implementationStartedAt: external_exports.string().optional(),
+  verificationStartedAt: external_exports.string().optional(),
+  closedAt: external_exports.string().optional(),
+  closedBy: external_exports.string().optional(),
+  cancelledAt: external_exports.string().optional(),
+  cancelledBy: external_exports.string().optional(),
+  dueDate: external_exports.string().optional()
+});
+var CapaListResponseSchema = external_exports.object({
+  items: external_exports.array(CapaResponseSchema),
+  total: external_exports.number(),
+  limit: external_exports.number(),
+  offset: external_exports.number()
+});
+var ComplaintStatusSchema = external_exports.enum(COMPLAINT_STATUSES);
+var ComplaintSeveritySchema = external_exports.enum(COMPLAINT_SEVERITIES);
+var ComplaintCategorySchema = external_exports.enum(COMPLAINT_CATEGORIES);
+var ComplaintSourceSchema = external_exports.enum(COMPLAINT_SOURCES);
+var QmsComplaintParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1)
+});
+var ComplaintIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1),
+  complaintId: external_exports.string().min(1)
+});
+var ComplainantSchema = external_exports.object({
+  name: external_exports.string().min(1).max(200),
+  email: external_exports.string().email().optional(),
+  phone: external_exports.string().max(50).optional(),
+  organization: external_exports.string().max(200).optional()
+});
+var CreateComplaintRequestSchema = external_exports.object({
+  title: external_exports.string().min(1).max(200),
+  description: external_exports.string().min(1).max(5e3),
+  severity: ComplaintSeveritySchema,
+  category: ComplaintCategorySchema,
+  source: ComplaintSourceSchema,
+  receivedDate: external_exports.string().datetime(),
+  complainant: ComplainantSchema,
+  reportable: external_exports.boolean(),
+  reportabilityJustification: external_exports.string().max(5e3).optional(),
+  affectedDeviceIds: external_exports.array(external_exports.string().min(1)).default([]),
+  affectedDocumentIds: external_exports.array(external_exports.string().min(1)).default([]),
+  assigneeId: external_exports.string().min(1).optional(),
+  dueDate: external_exports.string().datetime().optional()
+});
+var UpdateComplaintRequestSchema = external_exports.object({
+  title: external_exports.string().min(1).max(200).optional(),
+  description: external_exports.string().min(1).max(5e3).optional(),
+  severity: ComplaintSeveritySchema.optional(),
+  category: ComplaintCategorySchema.optional(),
+  source: ComplaintSourceSchema.optional(),
+  reportable: external_exports.boolean().optional(),
+  reportabilityJustification: external_exports.string().max(5e3).optional(),
+  investigationSummary: external_exports.string().max(5e3).optional(),
+  rootCauseDescription: external_exports.string().max(5e3).optional(),
+  resolutionDescription: external_exports.string().max(5e3).optional(),
+  affectedDeviceIds: external_exports.array(external_exports.string().min(1)).optional(),
+  affectedDocumentIds: external_exports.array(external_exports.string().min(1)).optional(),
+  assigneeId: external_exports.string().min(1).nullable().optional(),
+  dueDate: external_exports.string().datetime().nullable().optional()
+});
+var ResolveComplaintRequestSchema = external_exports.object({
+  resolutionDescription: external_exports.string().min(1).max(5e3)
+});
+var CloseComplaintRequestSchema = external_exports.object({
+  signatureId: external_exports.string().min(1)
+});
+var CancelComplaintRequestSchema = external_exports.object({
+  reason: external_exports.string().min(1).max(5e3)
+});
+var ComplaintListQuerySchema = PaginationParamsSchema.extend({
+  status: ComplaintStatusSchema.optional(),
+  severity: ComplaintSeveritySchema.optional(),
+  category: ComplaintCategorySchema.optional(),
+  source: ComplaintSourceSchema.optional()
+});
+var ComplaintResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  qmsId: external_exports.string(),
+  organizationId: external_exports.string(),
+  complaintNumber: external_exports.string(),
+  title: external_exports.string(),
+  description: external_exports.string(),
+  status: ComplaintStatusSchema,
+  severity: ComplaintSeveritySchema,
+  category: ComplaintCategorySchema,
+  source: ComplaintSourceSchema,
+  receivedDate: external_exports.string(),
+  complainant: ComplainantSchema,
+  reportable: external_exports.boolean(),
+  reportabilityJustification: external_exports.string().optional(),
+  investigationSummary: external_exports.string().optional(),
+  rootCauseDescription: external_exports.string().optional(),
+  resolutionDescription: external_exports.string().optional(),
+  affectedDeviceIds: external_exports.array(external_exports.string()),
+  affectedDocumentIds: external_exports.array(external_exports.string()),
+  linkedCapaId: external_exports.string().optional(),
+  assigneeId: external_exports.string().optional(),
+  assigneeEmail: external_exports.string().optional(),
+  dueDate: external_exports.string().optional(),
+  createdAt: external_exports.string(),
+  createdBy: external_exports.string(),
+  investigationStartedAt: external_exports.string().optional(),
+  resolvedAt: external_exports.string().optional(),
+  resolvedBy: external_exports.string().optional(),
+  closedAt: external_exports.string().optional(),
+  closedBy: external_exports.string().optional(),
+  cancellationReason: external_exports.string().optional(),
+  cancelledAt: external_exports.string().optional(),
+  cancelledBy: external_exports.string().optional()
+});
+var ComplaintListResponseSchema = external_exports.object({
+  items: external_exports.array(ComplaintResponseSchema),
+  total: external_exports.number(),
+  limit: external_exports.number(),
+  offset: external_exports.number()
+});
+var EscalateToCapaResponseSchema = external_exports.object({
+  capaId: external_exports.string()
+});
+var DCODocumentChangeTypeSchema = external_exports.enum(["new", "revision", "obsolete"]);
+var DCOStatusSchema = external_exports.enum(["draft", "pending_signatures", "approved", "effective"]);
+var DCOScopeSchema = external_exports.enum(["release", "documents", "maintenance"]);
+var DCODocumentEntrySchema = external_exports.object({
+  documentId: external_exports.string().min(1),
+  repositoryId: external_exports.string().min(1),
+  commitSha: external_exports.string().min(1),
+  changeType: DCODocumentChangeTypeSchema,
+  changeDescription: external_exports.string().min(1).max(2e3)
+});
+var CreateDCORequestSchema = external_exports.object({
+  title: external_exports.string().min(1).max(200),
+  description: external_exports.string().min(1).max(5e3),
+  scope: DCOScopeSchema,
+  effectiveDate: external_exports.string().datetime(),
+  documents: external_exports.array(DCODocumentEntrySchema).min(1),
+  /** Required when scope='release' */
+  releaseId: external_exports.string().min(1).optional()
+}).superRefine((data, ctx) => {
+  if (data.scope === "release" && !data.releaseId) {
+    ctx.addIssue({
+      code: external_exports.ZodIssueCode.custom,
+      message: 'releaseId is required when scope is "release"',
+      path: ["releaseId"]
+    });
+  }
+});
+var UpdateDCORequestSchema = external_exports.object({
+  title: external_exports.string().min(1).max(200).optional(),
+  description: external_exports.string().min(1).max(5e3).optional(),
+  effectiveDate: external_exports.string().datetime().optional(),
+  documents: external_exports.array(DCODocumentEntrySchema).min(1).optional()
+});
+var SubmitDCORequestSchema = external_exports.object({
+  departments: external_exports.array(external_exports.string().min(1)).min(1, "At least one department must be specified")
+});
+var FulfillDCOObligationRequestSchema = external_exports.object({
+  obligationId: external_exports.string().min(1),
+  meaning: external_exports.string().min(1).max(500),
+  /** Fresh ID token from re-authentication (Part 11 §11.200 compliance) */
+  idToken: external_exports.string().min(1),
+  /** Part 11: ID of the ERSD version the signer accepted */
+  ersdDisclosureId: external_exports.string().min(1),
+  /** Part 11: ISO date string when the signer accepted the ERSD */
+  ersdAcceptedAt: external_exports.string().datetime()
+});
+var DCOIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1),
+  dcoId: external_exports.string().min(1)
+});
+var QmsDCOParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1)
+});
+var DCOListQuerySchema = PaginationParamsSchema.extend({
+  status: DCOStatusSchema.optional(),
+  scope: DCOScopeSchema.optional()
+});
+var RevisionAssignmentSchema = external_exports.object({
+  documentId: external_exports.string(),
+  revisionNumber: external_exports.number()
+});
+var DCOSigningObligationSchema = external_exports.object({
+  obligationId: external_exports.string(),
+  department: external_exports.string(),
+  status: external_exports.enum(["pending", "fulfilled"]),
+  meaning: external_exports.string().optional(),
+  fulfilledBySignatureId: external_exports.string().optional(),
+  fulfilledAt: external_exports.string().optional()
+});
+var DCOResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  organizationId: external_exports.string(),
+  qmsId: external_exports.string(),
+  dcoNumber: external_exports.string(),
+  title: external_exports.string(),
+  description: external_exports.string(),
+  scope: DCOScopeSchema,
+  releaseId: external_exports.string().optional(),
+  documents: external_exports.array(DCODocumentEntrySchema),
+  status: DCOStatusSchema,
+  effectiveDate: external_exports.string(),
+  createdAt: external_exports.string(),
+  createdBy: external_exports.string(),
+  approvedAt: external_exports.string().optional(),
+  effectiveAt: external_exports.string().optional(),
+  revisionAssignments: external_exports.array(RevisionAssignmentSchema),
+  signingObligations: external_exports.array(DCOSigningObligationSchema)
+});
+var DCOListResponseSchema = external_exports.object({
+  items: external_exports.array(DCOResponseSchema),
+  total: external_exports.number(),
+  limit: external_exports.number(),
+  offset: external_exports.number()
+});
+var DocumentRevisionResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  revisionNumber: external_exports.number(),
+  dcoId: external_exports.string(),
+  dcoNumber: external_exports.string(),
+  releaseId: external_exports.string().optional(),
+  releaseName: external_exports.string().optional(),
+  commitSha: external_exports.string(),
+  changeType: DCODocumentChangeTypeSchema,
+  changeDescription: external_exports.string(),
+  effectiveAt: external_exports.string(),
+  effectiveBy: external_exports.string()
+});
+var RequestDCOExportResponseSchema = external_exports.object({
+  message: external_exports.string(),
+  estimatedMinutes: external_exports.number()
+});
 var RegulatoryFrameworkSchema = external_exports.enum([
   "ISO_13485",
   "IEC_62304",
@@ -21498,7 +22546,6 @@ var LinkTypeSchema = external_exports.enum([
   "analyzes"
 ]);
 var AcceptabilityStatusSchema = external_exports.enum(["acceptable", "review_required", "unacceptable"]);
-var DepartmentRoleSchema = external_exports.enum(["manager", "member"]);
 var RiskDocumentStatusSchema = external_exports.enum([
   "draft",
   "in_review",
@@ -21555,15 +22602,20 @@ var RiskEntryFrontmatterSchema = external_exports.object({
   harm_assessments: external_exports.array(HarmAssessmentSchema).min(1),
   mitigations: external_exports.array(MitigationSchema).optional(),
   cvss_score: external_exports.number().min(0).max(10).optional(),
-  cvss_vector: external_exports.string().regex(/^CVSS:3\.[01]\/AV:[NALP]\/AC:[LH]\/PR:[NLH]\/UI:[NR]\/S:[UC]\/C:[NLH]\/I:[NLH]\/A:[NLH]$/).optional()
-}).refine((data) => {
-  if (data.type === "security_risk") {
-    return data.harm_assessments.every((ha) => ha.inherent_exploitability != null);
+  cvss_vector: external_exports.string().regex(
+    /^CVSS:3\.[01]\/AV:[NALP]\/AC:[LH]\/PR:[NLH]\/UI:[NR]\/S:[UC]\/C:[NLH]\/I:[NLH]\/A:[NLH]$/
+  ).optional()
+}).refine(
+  (data) => {
+    if (data.type === "security_risk") {
+      return data.harm_assessments.every((ha) => ha.inherent_exploitability != null);
+    }
+    return data.harm_assessments.every((ha) => ha.inherent_probability != null);
+  },
+  {
+    message: "Security risks must use inherent_exploitability; software/usability risks must use inherent_probability"
   }
-  return data.harm_assessments.every((ha) => ha.inherent_probability != null);
-}, {
-  message: "Security risks must use inherent_exploitability; software/usability risks must use inherent_probability"
-});
+);
 var HazardFrontmatterSchema = external_exports.object({
   type: external_exports.enum(["haz_soe_software", "haz_soe_security"]),
   id: external_exports.string().min(1),
@@ -21613,10 +22665,12 @@ var RiskMatrixConfigSchema = external_exports.object({
     unacceptable: external_exports.array(external_exports.tuple([external_exports.number(), external_exports.number()])),
     review_required: external_exports.array(external_exports.tuple([external_exports.number(), external_exports.number()])).optional()
   }),
-  overrides: external_exports.record(external_exports.object({
-    unacceptable: external_exports.array(external_exports.tuple([external_exports.number(), external_exports.number()])),
-    review_required: external_exports.array(external_exports.tuple([external_exports.number(), external_exports.number()])).optional()
-  })).optional()
+  overrides: external_exports.record(
+    external_exports.object({
+      unacceptable: external_exports.array(external_exports.tuple([external_exports.number(), external_exports.number()])),
+      review_required: external_exports.array(external_exports.tuple([external_exports.number(), external_exports.number()])).optional()
+    })
+  ).optional()
 });
 var UsabilityPlanFrontmatterSchema = external_exports.object({
   type: external_exports.literal("usability_plan"),
@@ -22231,11 +23285,6 @@ var EmailAddressSchema = external_exports.object({
   value: external_exports.string().email(),
   verified: external_exports.boolean()
 });
-var ReviewerRuleSchema = external_exports.object({
-  documentType: DocumentTypeSchema,
-  requiredDepartments: external_exports.array(external_exports.string()),
-  finalApproverDepartment: external_exports.string()
-});
 var SyncStatusSchema = external_exports.enum(["active", "paused", "error"]);
 var AuditActionSchema = external_exports.enum([
   // Organization
@@ -22434,186 +23483,1995 @@ var ResourceTypeSchema = external_exports.enum([
   "audit_log",
   "risk_matrix"
 ]);
-var ReleaseTypeSchema = external_exports.enum(["qms", "device", "combined"]);
-var ReleaseStatusSchema = external_exports.enum(["draft", "in_review", "approved", "published"]);
-var SignatureTypeSchema = external_exports.enum(["author", "dept_reviewer", "final_approver", "trainee"]);
-var ChangeTypeSchema = external_exports.enum(["added", "modified", "deleted"]);
-var SigningRequestStatusSchema = external_exports.enum([
-  "sent",
-  "partially_signed",
-  "completed",
-  "expired",
-  "cancelled"
+var DocumentSourceTypeSchema = external_exports.enum([
+  "markdown",
+  "pdf"
 ]);
-var SignerStatusSchema = external_exports.enum(["pending", "viewed", "signed", "declined"]);
-var FieldTypeSchema = external_exports.enum(["signature", "initials", "date"]);
-var RISK_DOCUMENT_TYPES = [
-  "software_risk",
-  "usability_risk",
-  "security_risk"
-];
-var HAZARD_DOCUMENT_TYPES = ["haz_soe_software", "haz_soe_security"];
-var ALL_RISK_RELATED_DOCUMENT_TYPES = [
-  ...RISK_DOCUMENT_TYPES,
-  ...HAZARD_DOCUMENT_TYPES,
-  "hazardous_situation",
-  "harm"
-];
-var QMS_DOCUMENT_TYPES = [
-  "sop",
-  "policy",
-  "work_instruction",
-  "supplier",
-  // Internal audit management (ISO 13485 §8.2.2)
-  "audit_schedule",
-  "audit_report",
-  // Management review (ISO 13485 §5.6)
-  "management_review"
-];
-var DEVICE_DOCUMENT_TYPES = [
-  "user_need",
-  "requirement",
-  "architecture",
-  "detailed_design",
-  "test_protocol",
-  "test_report",
-  "usability_risk",
+var ChangeTypeSchema = external_exports.enum(["added", "modified", "removed"]);
+var GetDocumentsQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  repositoryId: external_exports.string().min(1).optional(),
+  docType: DocumentTypeSchema.optional(),
+  status: DocumentStatusSchema.optional(),
+  searchQuery: external_exports.string().optional(),
+  limit: external_exports.coerce.number().int().positive().max(200).default(50),
+  offset: external_exports.coerce.number().int().nonnegative().default(0)
+});
+var GetDocumentQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  includeChangelog: external_exports.string().transform((v) => v === "true").pipe(external_exports.boolean()).default("false")
+});
+var GetDocumentContentQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  commitSha: external_exports.string().min(1).optional()
+});
+var GetTraceabilityMatrixQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  repositoryId: external_exports.string().min(1).optional(),
+  sourceType: DocumentTypeSchema,
+  targetType: DocumentTypeSchema,
+  linkType: LinkTypeSchema,
+  statusFilter: external_exports.string().transform((v) => v.split(",").filter(Boolean)).pipe(external_exports.array(DocumentStatusSchema)).optional()
+});
+var GetGapsQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  repositoryId: external_exports.string().min(1).optional(),
+  docTypes: external_exports.string().transform((v) => v.split(",").filter(Boolean)).pipe(external_exports.array(DocumentTypeSchema)).optional()
+});
+var GetDeviceTraceabilityMatrixQuerySchema = external_exports.object({
+  sourceType: DocumentTypeSchema,
+  targetType: DocumentTypeSchema,
+  linkType: LinkTypeSchema,
+  statusFilter: external_exports.string().transform((v) => v.split(",").filter(Boolean)).pipe(external_exports.array(DocumentStatusSchema)).optional()
+});
+var GetDeviceGapsQuerySchema = external_exports.object({
+  docTypes: external_exports.string().transform((v) => v.split(",").filter(Boolean)).pipe(external_exports.array(DocumentTypeSchema)).optional()
+});
+var DocumentIdParamSchema = external_exports.object({
+  documentId: external_exports.string().min(1)
+});
+var ChangelogEntryResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  changeType: ChangeTypeSchema,
+  commitSha: external_exports.string(),
+  previousCommitSha: external_exports.string().optional(),
+  changedBy: external_exports.string().optional(),
+  changedByEmail: external_exports.string().optional(),
+  changedAt: external_exports.string(),
+  // ISO datetime
+  pullRequestNumber: external_exports.number().optional(),
+  pullRequestTitle: external_exports.string().optional(),
+  releaseId: external_exports.string().optional(),
+  releaseName: external_exports.string().optional(),
+  changeSummary: external_exports.string().optional()
+});
+var LinkResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  sourceDocumentId: external_exports.string(),
+  targetDocumentId: external_exports.string(),
+  linkType: LinkTypeSchema,
+  sourceDocPath: external_exports.string(),
+  targetDocPath: external_exports.string(),
+  sourceRepositoryId: external_exports.string(),
+  targetRepositoryId: external_exports.string().optional(),
+  rationale: external_exports.string().optional()
+});
+var DocumentSummaryResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  documentId: external_exports.string(),
+  title: external_exports.string(),
+  docType: DocumentTypeSchema,
+  status: DocumentStatusSchema,
+  sourceType: DocumentSourceTypeSchema,
+  path: external_exports.string(),
+  repositoryId: external_exports.string(),
+  repositoryName: external_exports.string(),
+  repositoryType: external_exports.enum(["qms", "device"]),
+  lastSyncedAt: external_exports.string(),
+  // ISO datetime
+  metadata: external_exports.record(external_exports.string(), external_exports.unknown()).optional()
+});
+var DocumentDetailResponseSchema = DocumentSummaryResponseSchema.extend({
+  metadata: external_exports.record(external_exports.string(), external_exports.unknown()),
+  currentCommitSha: external_exports.string(),
+  sourcePath: external_exports.string().nullable(),
+  changelog: external_exports.array(ChangelogEntryResponseSchema).optional(),
+  incomingLinks: external_exports.array(LinkResponseSchema).optional(),
+  outgoingLinks: external_exports.array(LinkResponseSchema).optional()
+});
+var DocumentContentResponseSchema = external_exports.object({
+  content: external_exports.string(),
+  commitSha: external_exports.string(),
+  path: external_exports.string(),
+  githubUrl: external_exports.string()
+});
+var GetDocumentsResponseSchema = external_exports.object({
+  documents: external_exports.array(DocumentSummaryResponseSchema),
+  total: external_exports.number(),
+  limit: external_exports.number(),
+  offset: external_exports.number()
+});
+var TraceabilityRowSchema = external_exports.object({
+  sourceId: external_exports.string(),
+  sourceDocumentId: external_exports.string(),
+  sourceTitle: external_exports.string(),
+  sourcePath: external_exports.string(),
+  linked: external_exports.boolean(),
+  targetIds: external_exports.array(external_exports.string()),
+  targetDocumentIds: external_exports.array(external_exports.string()),
+  targetTitles: external_exports.array(external_exports.string())
+});
+var TraceabilityMatrixResponseSchema = external_exports.object({
+  sourceType: DocumentTypeSchema,
+  targetType: DocumentTypeSchema,
+  linkType: LinkTypeSchema,
+  coveragePercent: external_exports.number(),
+  totalSources: external_exports.number(),
+  coveredSources: external_exports.number(),
+  rows: external_exports.array(TraceabilityRowSchema)
+});
+var GapItemSchema = external_exports.object({
+  documentId: external_exports.string(),
+  documentTitle: external_exports.string(),
+  documentPath: external_exports.string(),
+  docType: DocumentTypeSchema,
+  missingLinkType: LinkTypeSchema,
+  expectedTargetType: DocumentTypeSchema
+});
+var GapsResponseSchema = external_exports.object({
+  totalGaps: external_exports.number(),
+  gaps: external_exports.array(GapItemSchema)
+});
+var ComponentResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  componentName: external_exports.string(),
+  version: external_exports.string(),
+  license: external_exports.string().optional(),
+  safetyRiskClass: external_exports.string().optional(),
+  purpose: external_exports.string().optional(),
+  verification: external_exports.string().optional(),
+  cveStatus: external_exports.string().optional(),
+  category: external_exports.string().optional(),
+  supplierId: external_exports.string().optional(),
+  sourceFormat: external_exports.enum(["markdown_table", "cyclonedx", "spdx"]),
+  purl: external_exports.string().optional()
+});
+var GetComponentsResponseSchema = external_exports.array(ComponentResponseSchema);
+var DocumentSignoffObligationSchema = external_exports.object({
+  obligationId: external_exports.string(),
+  role: external_exports.enum(["author", "reviewer", "approver"]),
+  department: external_exports.string(),
+  status: external_exports.enum(["pending", "fulfilled"]),
+  fulfilledByUserId: external_exports.string().optional(),
+  fulfilledByUserEmail: external_exports.string().optional(),
+  fulfilledByUserDisplayName: external_exports.string().optional(),
+  fulfilledAt: external_exports.string().optional(),
+  signatureId: external_exports.string().optional()
+});
+var DocumentSignoffStatusResponseSchema = external_exports.object({
+  documentId: external_exports.string(),
+  commitSha: external_exports.string(),
+  obligations: external_exports.array(DocumentSignoffObligationSchema),
+  progress: external_exports.object({
+    total: external_exports.number(),
+    fulfilled: external_exports.number(),
+    isComplete: external_exports.boolean()
+  })
+});
+var DocumentExportResponseSchema = external_exports.object({
+  message: external_exports.string()
+});
+var CompiledDocumentPresetSchema = external_exports.enum(["srs", "prs", "dmr", "risk"]);
+var CompiledDocumentQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  repositoryId: external_exports.string().min(1).optional(),
+  docType: DocumentTypeSchema.optional(),
+  category: external_exports.string().optional(),
+  status: DocumentStatusSchema.optional(),
+  preset: CompiledDocumentPresetSchema.optional()
+}).refine((data) => data.preset || data.docType, {
+  message: "Either preset or docType must be provided"
+});
+var CompiledTableOfContentsEntrySchema = external_exports.object({
+  documentId: external_exports.string(),
+  title: external_exports.string(),
+  anchor: external_exports.string()
+});
+var CompiledDocumentItemSchema = external_exports.object({
+  documentId: external_exports.string(),
+  title: external_exports.string(),
+  docType: DocumentTypeSchema,
+  status: DocumentStatusSchema,
+  path: external_exports.string(),
+  content: external_exports.string(),
+  anchor: external_exports.string()
+});
+var CompiledDocumentResponseSchema = external_exports.object({
+  title: external_exports.string(),
+  generatedAt: external_exports.string(),
+  documentCount: external_exports.number(),
+  tableOfContents: external_exports.array(CompiledTableOfContentsEntrySchema),
+  documents: external_exports.array(CompiledDocumentItemSchema)
+});
+var DepartmentRoleSchema = external_exports.enum(["manager", "member"]);
+var ReviewerRuleSchema = external_exports.object({
+  documentType: external_exports.string(),
+  requiredDepartments: external_exports.array(external_exports.string()),
+  finalApproverDepartment: external_exports.string()
+});
+var RoleSchema2 = external_exports.enum(["admin", "member", "auditor"]);
+var AuditorTypeSchema = external_exports.enum(["internal", "external"]);
+var CreateOrganizationRequestSchema = external_exports.object({
+  name: external_exports.string().min(3).max(100),
+  frameworks: external_exports.array(RegulatoryFrameworkSchema).min(1),
+  department: external_exports.string().min(1)
+});
+var ChecklistTemplateItemSchema = external_exports.object({
+  id: external_exports.string().min(1),
+  label: external_exports.string().min(1).max(500),
+  sortOrder: external_exports.number().int().nonnegative()
+});
+var UpdateOrganizationSettingsRequestSchema = external_exports.object({
+  name: external_exports.string().min(1).optional(),
+  frameworks: external_exports.array(RegulatoryFrameworkSchema).optional(),
+  departments: external_exports.array(external_exports.string()).optional(),
+  reviewerRules: external_exports.array(ReviewerRuleSchema).optional(),
+  releaseChecklistTemplate: external_exports.array(ChecklistTemplateItemSchema).max(30).optional()
+});
+var UpdateMemberRequestSchema = external_exports.object({
+  department: external_exports.string().optional(),
+  role: RoleSchema2.optional(),
+  departmentRole: DepartmentRoleSchema.optional()
+});
+var InviteUserRequestSchema = external_exports.object({
+  email: external_exports.string().email(),
+  department: external_exports.string().min(1),
+  role: RoleSchema2,
+  departmentRole: DepartmentRoleSchema.optional(),
+  auditorType: AuditorTypeSchema.optional(),
+  accessExpiresAt: external_exports.string().datetime().optional()
+}).superRefine((data, ctx) => {
+  if (data.role === "auditor" && !data.auditorType) {
+    ctx.addIssue({
+      code: external_exports.ZodIssueCode.custom,
+      message: "auditorType is required when role is auditor",
+      path: ["auditorType"]
+    });
+  }
+  if (data.role !== "auditor" && data.auditorType) {
+    ctx.addIssue({
+      code: external_exports.ZodIssueCode.custom,
+      message: "auditorType is only valid for auditor role",
+      path: ["auditorType"]
+    });
+  }
+  if (data.role !== "auditor" && data.accessExpiresAt) {
+    ctx.addIssue({
+      code: external_exports.ZodIssueCode.custom,
+      message: "accessExpiresAt is only valid for auditor role",
+      path: ["accessExpiresAt"]
+    });
+  }
+});
+var AcceptInviteRequestSchema = external_exports.object({
+  token: external_exports.string().min(1)
+});
+var UpdateProfileRequestSchema = external_exports.object({
+  displayName: external_exports.string().min(1).max(100).optional()
+});
+var OrgIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1)
+});
+var MemberIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  memberId: external_exports.string().min(1)
+});
+var InviteIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  inviteId: external_exports.string().min(1)
+});
+var SubscriptionStatusSchema = external_exports.enum([
+  "active",
+  "trialing",
+  "past_due",
+  "canceled",
+  "incomplete"
+]);
+var SubscriptionResponseSchema = external_exports.object({
+  status: SubscriptionStatusSchema,
+  currentPeriodEnd: external_exports.string(),
+  cancelAtPeriodEnd: external_exports.boolean()
+});
+var CreateCheckoutSessionResponseSchema = external_exports.object({
+  checkoutUrl: external_exports.string().url()
+});
+var CreatePortalSessionResponseSchema = external_exports.object({
+  portalUrl: external_exports.string().url()
+});
+var InviteStatusSchema = external_exports.enum(["pending", "accepted", "expired", "revoked"]);
+var MemberResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  email: external_exports.string().email(),
+  emailVerified: external_exports.boolean(),
+  displayName: external_exports.string(),
+  department: external_exports.string(),
+  departmentRole: DepartmentRoleSchema.optional(),
+  role: RoleSchema2,
+  auditorType: AuditorTypeSchema.optional(),
+  accessExpiresAt: external_exports.string().optional(),
+  // ISO date (for external auditors)
+  status: MemberStatusSchema,
+  joinedAt: external_exports.string()
+  // ISO date
+});
+var InviteResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  email: external_exports.string().email(),
+  department: external_exports.string(),
+  role: RoleSchema2,
+  status: InviteStatusSchema,
+  expiresAt: external_exports.string(),
+  // ISO date
+  createdAt: external_exports.string()
+  // ISO date
+});
+var OrganizationResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  name: external_exports.string(),
+  role: RoleSchema2,
+  department: external_exports.string(),
+  gitHubAppInstallationId: external_exports.number().optional(),
+  gitHubOrgName: external_exports.string().optional(),
+  subscription: SubscriptionResponseSchema.optional()
+});
+var OrganizationSettingsResponseSchema = external_exports.object({
+  frameworks: external_exports.array(external_exports.string()),
+  departments: external_exports.array(external_exports.string()),
+  defaultSafetyClass: SafetyClassSchema,
+  reviewerRules: external_exports.array(ReviewerRuleSchema),
+  releaseChecklistTemplate: external_exports.array(ChecklistTemplateItemSchema).optional()
+});
+var CreateOrganizationResponseSchema = external_exports.object({
+  organizationId: external_exports.string()
+});
+var GetOrganizationsResponseSchema = external_exports.object({
+  organizations: external_exports.array(OrganizationResponseSchema)
+});
+var GetMembersResponseSchema = external_exports.object({
+  members: external_exports.array(MemberResponseSchema)
+});
+var GetInvitesResponseSchema = external_exports.object({
+  invites: external_exports.array(InviteResponseSchema)
+});
+var AcceptInviteResponseSchema = external_exports.object({
+  organizationId: external_exports.string(),
+  organizationName: external_exports.string()
+});
+var PendingInviteResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  organizationId: external_exports.string(),
+  organizationName: external_exports.string(),
+  invitedByName: external_exports.string(),
+  role: RoleSchema2,
+  department: external_exports.string(),
+  createdAt: external_exports.string(),
+  expiresAt: external_exports.string()
+});
+var GetPendingInvitesResponseSchema = external_exports.object({
+  invites: external_exports.array(PendingInviteResponseSchema)
+});
+var SuccessResponseSchema = external_exports.object({
+  success: external_exports.boolean()
+});
+var ValidateInviteResponseSchema = external_exports.object({
+  organizationName: external_exports.string(),
+  status: InviteStatusSchema
+});
+var CreateInviteResponseSchema = external_exports.object({
+  inviteId: external_exports.string()
+});
+var LegalAcceptRequestSchema = external_exports.object({
+  documentType: LegalDocumentTypeSchema,
+  documentVersion: LegalDocumentVersionSchema,
+  organizationId: external_exports.string().optional()
+}).superRefine((data, ctx) => {
+  if (data.documentType === "billing-terms" && !data.organizationId) {
+    ctx.addIssue({
+      code: external_exports.ZodIssueCode.custom,
+      message: "organizationId is required for billing-terms",
+      path: ["organizationId"]
+    });
+  }
+});
+var LegalHistoryQuerySchema = external_exports.object({
+  pageToken: external_exports.string().optional(),
+  limit: external_exports.coerce.number().min(1).max(100).default(20)
+});
+var LegalAcceptResponseSchema = external_exports.object({
+  acceptanceId: external_exports.string(),
+  acceptedAt: external_exports.string()
+});
+var DocumentStatusSchema2 = external_exports.object({
+  accepted: external_exports.boolean(),
+  acceptedVersion: external_exports.string().optional(),
+  currentVersion: external_exports.string()
+});
+var LegalStatusResponseSchema = external_exports.object({
+  tos: DocumentStatusSchema2,
+  privacyPolicy: DocumentStatusSchema2,
+  billingTerms: external_exports.record(external_exports.string(), DocumentStatusSchema2)
+});
+var LegalHistoryResponseSchema = external_exports.object({
+  acceptances: external_exports.array(
+    external_exports.object({
+      id: external_exports.string(),
+      documentType: LegalDocumentTypeSchema,
+      documentVersion: external_exports.string(),
+      organizationId: external_exports.string().optional(),
+      acceptedAt: external_exports.string()
+    })
+  ),
+  nextPageToken: external_exports.string().optional()
+});
+var RepositoryTypeSchema = external_exports.enum(["qms", "device"]);
+var ConnectRepositoryRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  gitHubRepoFullName: external_exports.string().min(1),
+  gitHubRepoId: external_exports.number().int().positive()
+});
+var RepositoryIdParamSchema = external_exports.object({
+  repositoryId: external_exports.string().min(1)
+});
+var OrgRepositoryParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  repositoryId: external_exports.string().min(1)
+});
+var OrgIdQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1)
+});
+var AssignRepositoryRequestSchema = external_exports.object({
+  ownerType: OwnerTypeSchema,
+  ownerId: external_exports.string().min(1)
+});
+var TriggerSyncRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1)
+});
+var SyncEventParamSchema = external_exports.object({
+  repositoryId: external_exports.string().min(1),
+  syncEventId: external_exports.string().min(1)
+});
+var DocumentCountsSchema = external_exports.record(external_exports.string(), external_exports.number());
+var LinkCountsSchema = external_exports.record(external_exports.string(), external_exports.number());
+var RepositorySnapshotSchema = external_exports.object({
+  documentCounts: DocumentCountsSchema,
+  linkCounts: LinkCountsSchema,
+  totalDocuments: external_exports.number(),
+  totalLinks: external_exports.number()
+});
+var BaseFieldsSchema = external_exports.object({
+  id: external_exports.string(),
+  organizationId: external_exports.string(),
+  ownerType: external_exports.enum(["qms", "device"]).nullable(),
+  ownerId: external_exports.string().nullable(),
+  gitHubRepoFullName: external_exports.string(),
+  gitHubRepoId: external_exports.number(),
+  syncStatus: SyncStatusSchema,
+  lastSyncedAt: external_exports.string().optional(),
+  // ISO date
+  lastSyncCommitSha: external_exports.string().optional(),
+  connectedAt: external_exports.string(),
+  // ISO date
+  connectedBy: external_exports.string(),
+  snapshot: RepositorySnapshotSchema.optional()
+});
+var UnassignedRepositoryResponseSchema = BaseFieldsSchema.extend({
+  type: external_exports.literal("unassigned")
+});
+var QmsRepositoryResponseSchema = BaseFieldsSchema.extend({
+  type: external_exports.literal("qms")
+});
+var DeviceRepositoryResponseSchema = BaseFieldsSchema.extend({
+  type: external_exports.literal("device"),
+  deviceName: external_exports.string(),
+  safetyClass: SafetyClassSchema,
+  configManaged: external_exports.boolean().optional()
+});
+var RepositoryResponseSchema = external_exports.discriminatedUnion("type", [
+  UnassignedRepositoryResponseSchema,
+  QmsRepositoryResponseSchema,
+  DeviceRepositoryResponseSchema
+]);
+var BaseRepositoryResponseSchema = BaseFieldsSchema.extend({
+  type: external_exports.enum(["unassigned", "qms", "device"])
+});
+var GitHubRepositoryResponseSchema = external_exports.object({
+  id: external_exports.number(),
+  fullName: external_exports.string(),
+  name: external_exports.string(),
+  private: external_exports.boolean(),
+  defaultBranch: external_exports.string()
+});
+var ConnectRepositoryResponseSchema = external_exports.object({
+  repositoryId: external_exports.string()
+});
+var GetRepositoriesResponseSchema = external_exports.object({
+  repositories: external_exports.array(RepositoryResponseSchema)
+});
+var ListGitHubReposResponseSchema = external_exports.object({
+  repositories: external_exports.array(GitHubRepositoryResponseSchema)
+});
+var TriggerSyncResponseSchema = external_exports.object({
+  syncEventId: external_exports.string()
+});
+var SyncEventStatusSchema = external_exports.enum([
+  "pending",
+  "in_progress",
+  "completed",
+  "completed_with_errors",
+  "failed"
+]);
+var SyncTriggerSchema = external_exports.enum(["manual", "webhook", "scheduled"]);
+var SyncEventResultSchema = external_exports.object({
+  documentsCreated: external_exports.number(),
+  documentsUpdated: external_exports.number(),
+  documentsRemoved: external_exports.number(),
+  linksCreated: external_exports.number(),
+  linksRemoved: external_exports.number(),
+  errors: external_exports.array(external_exports.string()),
+  commitSha: external_exports.string(),
+  repoConfig: external_exports.object({
+    device: external_exports.object({
+      name: external_exports.string(),
+      safety_class: external_exports.enum(["A", "B", "C"]),
+      classification: external_exports.object({
+        eu: external_exports.string().optional(),
+        us: external_exports.string().optional()
+      }).optional()
+    })
+  }).optional()
+});
+var SyncEventResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  status: SyncEventStatusSchema,
+  trigger: SyncTriggerSchema,
+  createdAt: external_exports.string(),
+  // ISO date
+  createdBy: external_exports.string(),
+  startedAt: external_exports.string().optional(),
+  completedAt: external_exports.string().optional(),
+  error: external_exports.string().optional(),
+  result: SyncEventResultSchema.optional()
+});
+var GetSyncEventResponseSchema = external_exports.object({
+  syncEvent: SyncEventResponseSchema
+});
+var RiskTypeSchema = external_exports.enum(["software_risk", "usability_risk", "security_risk"]);
+var GetRiskMatrixQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  repositoryId: external_exports.string().optional(),
+  type: RiskTypeSchema.optional()
+});
+var GetRiskGapsQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  repositoryId: external_exports.string().optional(),
+  type: RiskTypeSchema.optional()
+});
+var GetRiskListQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  repositoryId: external_exports.string().optional(),
+  type: RiskTypeSchema.optional(),
+  limit: external_exports.coerce.number().min(1).max(100).optional().default(50)
+});
+var RiskValueSchema = external_exports.number().int().min(1).max(5);
+var RiskDocumentTypeSchema = external_exports.enum([
   "software_risk",
+  "usability_risk",
   "security_risk",
-  "hazardous_situation",
-  "harm",
   "haz_soe_software",
   "haz_soe_security",
-  "hazard_category",
-  // Usability engineering (IEC 62366)
-  "usability_plan",
-  "use_specification",
-  "task_analysis",
-  "usability_evaluation",
-  "summative_evaluation",
-  // Risk management (ISO 14971)
-  "risk_management_plan",
-  // Software lifecycle (IEC 62304)
-  "software_development_plan",
-  "software_maintenance_plan",
-  "soup_register",
-  // Problem resolution (IEC 62304 §9)
-  "anomaly",
-  // Cybersecurity (IEC 81001-5-1)
-  "cybersecurity_plan",
-  "sbom",
-  // Clinical (MDR / FDA)
-  "clinical_evaluation_plan",
-  "clinical_evaluation_report",
-  // Post-market surveillance (MDR Art. 83)
-  "post_market_surveillance_plan",
-  "post_market_feedback",
-  // Labeling (MDR Annex I)
-  "labeling",
-  // Product (ISO 13485 §7.3)
-  "product_development_plan",
-  "intended_use",
-  // Release management (IEC 62304 §5.7)
-  "release_plan",
-  // Change management (ISO 13485 §7.3.5)
-  "design_review",
-  "release_notes",
-  // Software test plan (IEC 62304 §5.7)
-  "software_test_plan"
+  "hazardous_situation",
+  "harm",
+  "hazard_category"
+]);
+var HarmAssessmentEntrySchema = external_exports.object({
+  harm: external_exports.string(),
+  harmTitle: external_exports.string().optional(),
+  harmSeverity: RiskValueSchema,
+  inherentProbability: RiskValueSchema,
+  residualProbability: RiskValueSchema,
+  residualSeverityOverride: RiskValueSchema.optional(),
+  residualSeverity: RiskValueSchema,
+  inherentAcceptability: AcceptabilityStatusSchema,
+  residualAcceptability: AcceptabilityStatusSchema
+});
+var RiskEntrySchema = external_exports.object({
+  id: external_exports.string(),
+  type: RiskDocumentTypeSchema,
+  harmAssessments: external_exports.array(HarmAssessmentEntrySchema),
+  worstInherentSeverity: RiskValueSchema.optional(),
+  worstInherentProbability: RiskValueSchema.optional(),
+  worstResidualSeverity: RiskValueSchema.optional(),
+  worstResidualProbability: RiskValueSchema.optional(),
+  worstAcceptability: AcceptabilityStatusSchema.optional(),
+  cvssScore: external_exports.number().min(0).max(10).optional(),
+  cvssVector: external_exports.string().optional()
+});
+var RiskMatrixResponseSchema = external_exports.object({
+  inherent: external_exports.array(external_exports.array(external_exports.number())),
+  residual: external_exports.array(external_exports.array(external_exports.number())),
+  acceptability: external_exports.array(external_exports.array(AcceptabilityStatusSchema)),
+  summary: external_exports.object({
+    total: external_exports.number(),
+    acceptable: external_exports.number(),
+    reviewRequired: external_exports.number(),
+    unacceptable: external_exports.number()
+  }),
+  labels: external_exports.object({
+    severity: external_exports.array(external_exports.string()),
+    probability: external_exports.array(external_exports.string())
+  })
+});
+var RiskGapSchema = external_exports.object({
+  code: external_exports.string(),
+  severity: external_exports.enum(["error", "warning"]),
+  documentId: external_exports.string(),
+  documentTitle: external_exports.string(),
+  message: external_exports.string(),
+  repositoryId: external_exports.string().optional(),
+  repositoryName: external_exports.string().optional()
+});
+var RiskGapsResponseSchema = external_exports.object({
+  gaps: external_exports.array(RiskGapSchema),
+  byType: external_exports.record(external_exports.array(RiskGapSchema))
+});
+var RiskListItemSchema = external_exports.object({
+  id: external_exports.string(),
+  documentId: external_exports.string(),
+  title: external_exports.string(),
+  type: RiskDocumentTypeSchema,
+  harmAssessmentCount: external_exports.number().int().min(0),
+  worstInherentSeverity: RiskValueSchema.optional(),
+  worstInherentProbability: RiskValueSchema.optional(),
+  worstResidualSeverity: RiskValueSchema.optional(),
+  worstResidualProbability: RiskValueSchema.optional(),
+  worstAcceptability: AcceptabilityStatusSchema.optional(),
+  mitigationsCount: external_exports.number().int().min(0),
+  hasRiskBenefit: external_exports.boolean(),
+  cvssScore: external_exports.number().min(0).max(10).optional(),
+  cvssVector: external_exports.string().optional()
+});
+var RiskListResponseSchema = external_exports.object({
+  risks: external_exports.array(RiskListItemSchema),
+  total: external_exports.number()
+});
+var ReleaseTypeSchema = external_exports.enum(["qms", "device"]);
+var ReleaseStatusSchema = external_exports.enum(["draft", "in_review", "approved", "published"]);
+var SignatureTypeSchema = external_exports.enum([
+  "author",
+  "reviewer",
+  "approver",
+  "dept_reviewer",
+  "final_approver",
+  "trainee",
+  "trainer"
+]);
+var ReleaseChangeTypeSchema = external_exports.enum(["added", "modified", "removed"]);
+var ListReleasesQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  status: ReleaseStatusSchema.optional(),
+  type: ReleaseTypeSchema.optional(),
+  deviceId: external_exports.string().optional(),
+  limit: external_exports.coerce.number().int().positive().max(100).default(50),
+  offset: external_exports.coerce.number().int().nonnegative().default(0)
+});
+var GetReleaseQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  includeSignatures: external_exports.string().transform((v) => v === "true").pipe(external_exports.boolean()).default("false"),
+  includeSnapshot: external_exports.string().transform((v) => v === "true").pipe(external_exports.boolean()).default("false")
+});
+var GetSignaturesQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1)
+});
+var GetChangedDocumentsQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  type: ReleaseTypeSchema,
+  deviceId: external_exports.string().optional()
+});
+var ReleaseIdParamSchema = external_exports.object({
+  releaseId: external_exports.string().min(1)
+});
+var DHRMarketEntrySchema = external_exports.object({
+  country: external_exports.string().min(1),
+  clinicalEvaluation: external_exports.boolean()
+});
+var DHRTestEvidenceEntrySchema = external_exports.object({
+  label: external_exports.string().min(1),
+  url: external_exports.string().url()
+});
+var DHRMetadataSchema = external_exports.object({
+  markets: external_exports.array(DHRMarketEntrySchema).default([]),
+  udi: external_exports.string().nullable().default(null),
+  automatedTestEvidence: external_exports.array(DHRTestEvidenceEntrySchema).default([])
+});
+var DeploymentReferenceTypeSchema = external_exports.enum([
+  "artifact",
+  "pipeline",
+  "deployment",
+  "other"
+]);
+var DeploymentReferenceSchema = external_exports.object({
+  label: external_exports.string().min(1).max(200),
+  url: external_exports.string().url(),
+  type: DeploymentReferenceTypeSchema
+});
+var CreateReleaseRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  name: external_exports.string().min(1).max(200),
+  description: external_exports.string().max(2e3).optional(),
+  type: ReleaseTypeSchema,
+  deviceId: external_exports.string().optional(),
+  releasePlanDocumentId: external_exports.string().min(1).optional(),
+  designReviewId: external_exports.string().min(1).optional(),
+  releaseNotesDocumentId: external_exports.string().min(1).optional(),
+  deviationNotes: external_exports.string().max(5e3).optional(),
+  dhr: DHRMetadataSchema.optional(),
+  reason: external_exports.string().max(500).optional()
+}).strict();
+var UpdateReleaseRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  name: external_exports.string().min(1).max(200).optional(),
+  description: external_exports.string().max(2e3).optional(),
+  releasePlanDocumentId: external_exports.string().min(1).nullable().optional(),
+  designReviewId: external_exports.string().min(1).nullable().optional(),
+  releaseNotesDocumentId: external_exports.string().min(1).nullable().optional(),
+  deviationNotes: external_exports.string().max(5e3).optional(),
+  dhr: DHRMetadataSchema.nullable().optional(),
+  deploymentReferences: external_exports.array(DeploymentReferenceSchema).optional(),
+  smokeTestEvidence: external_exports.array(DHRTestEvidenceEntrySchema).optional(),
+  reason: external_exports.string().max(500).optional()
+}).strict();
+var AddSignatureRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  obligationId: external_exports.string().min(1),
+  meaning: external_exports.string().min(1).max(500),
+  /** Fresh Firebase ID token for per-signature re-authentication (Part 11 §11.200) */
+  idToken: external_exports.string().min(1).optional(),
+  /** Part 11: ID of the ERSD version the signer accepted */
+  ersdDisclosureId: external_exports.string().min(1),
+  /** Part 11: ISO date string when the signer accepted the ERSD */
+  ersdAcceptedAt: external_exports.string().datetime()
+}).strict();
+var SubmitReleaseRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  reason: external_exports.string().max(500).optional()
+});
+var WithdrawReleaseRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  reason: external_exports.string().max(500).optional()
+});
+var PublishReleaseRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  reason: external_exports.string().max(500).optional()
+});
+var DeleteReleaseQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1)
+});
+var UpdateChecklistItemParamSchema = external_exports.object({
+  releaseId: external_exports.string().min(1),
+  templateItemId: external_exports.string().min(1)
+});
+var UpdateChecklistItemRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  checked: external_exports.boolean(),
+  evidence: external_exports.string().max(2e3).optional()
+}).strict();
+var GateOverrideCategoryParamSchema = external_exports.object({
+  releaseId: external_exports.string().min(1),
+  category: GateOverrideCategorySchema
+});
+var AddGateOverrideRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  category: GateOverrideCategorySchema,
+  justification: external_exports.string().min(20).max(2e3)
+}).strict();
+var RemoveGateOverrideQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1)
+});
+var ReleaseChangeResponseSchema = external_exports.object({
+  repositoryId: external_exports.string(),
+  documentId: external_exports.string(),
+  documentPath: external_exports.string(),
+  documentTitle: external_exports.string(),
+  documentType: external_exports.string(),
+  commitSha: external_exports.string(),
+  changeType: ReleaseChangeTypeSchema
+});
+var SignatureResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  releaseId: external_exports.string(),
+  obligationId: external_exports.string(),
+  userId: external_exports.string(),
+  userEmail: external_exports.string(),
+  userDisplayName: external_exports.string(),
+  userDepartment: external_exports.string(),
+  signatureType: SignatureTypeSchema,
+  meaning: external_exports.string(),
+  timestamp: external_exports.string(),
+  // ISO datetime
+  signedCommitShas: external_exports.array(external_exports.string())
+});
+var SigningObligationRoleSchema = external_exports.enum(["author", "reviewer", "approver"]);
+var SigningObligationStatusSchema = external_exports.enum(["pending", "fulfilled"]);
+var SigningObligationResponseSchema = external_exports.object({
+  obligationId: external_exports.string(),
+  role: SigningObligationRoleSchema,
+  department: external_exports.string(),
+  documentIds: external_exports.array(external_exports.string()),
+  status: SigningObligationStatusSchema,
+  fulfilledBySignatureId: external_exports.string().optional(),
+  fulfilledAt: external_exports.string().optional()
+});
+var SigningObligationsSummarySchema = external_exports.object({
+  total: external_exports.number(),
+  fulfilled: external_exports.number(),
+  pending: external_exports.number()
+});
+var SnapshotLinkSchema = external_exports.object({
+  sourceDocumentId: external_exports.string(),
+  targetDocumentId: external_exports.string(),
+  linkType: external_exports.string()
+});
+var RiskMatrixCellSchema = external_exports.object({
+  count: external_exports.number(),
+  acceptability: external_exports.enum(["acceptable", "review_required", "unacceptable"])
+});
+var SnapshotGapSchema = external_exports.object({
+  code: external_exports.string(),
+  severity: external_exports.enum(["error", "warning"]),
+  documentId: external_exports.string(),
+  documentTitle: external_exports.string(),
+  message: external_exports.string()
+});
+var SnapshotTraceabilityChainEntrySchema = external_exports.object({
+  hazardId: external_exports.string(),
+  hazardTitle: external_exports.string(),
+  situationId: external_exports.string(),
+  situationTitle: external_exports.string(),
+  harmId: external_exports.string(),
+  harmTitle: external_exports.string(),
+  riskId: external_exports.string(),
+  riskTitle: external_exports.string(),
+  riskType: external_exports.string(),
+  inherentSeverity: external_exports.number(),
+  inherentProbability: external_exports.number(),
+  residualSeverity: external_exports.number(),
+  residualProbability: external_exports.number(),
+  acceptability: external_exports.string(),
+  controls: external_exports.array(external_exports.string()),
+  cvssScore: external_exports.number().optional(),
+  cvssVector: external_exports.string().optional()
+});
+var SnapshotPlanReferenceSchema = external_exports.object({
+  documentId: external_exports.string(),
+  title: external_exports.string(),
+  commitSha: external_exports.string(),
+  safetyClass: external_exports.string(),
+  postProductionReference: external_exports.string().optional()
+});
+var ComponentSnapshotEntryResponseSchema = external_exports.object({
+  componentName: external_exports.string(),
+  version: external_exports.string(),
+  license: external_exports.string().optional(),
+  safetyRiskClass: external_exports.string().optional(),
+  sourceFormat: external_exports.enum(["markdown_table", "cyclonedx", "spdx"])
+});
+var ReleaseSnapshotResponseSchema = external_exports.object({
+  traceabilityLinks: external_exports.array(SnapshotLinkSchema),
+  traceabilityCoverage: external_exports.number(),
+  riskMatrix: external_exports.object({
+    inherent: external_exports.array(external_exports.array(external_exports.number())),
+    residual: external_exports.array(external_exports.array(external_exports.number())),
+    acceptability: external_exports.array(external_exports.array(external_exports.enum(["acceptable", "review_required", "unacceptable"]))),
+    summary: external_exports.object({
+      total: external_exports.number(),
+      acceptable: external_exports.number(),
+      reviewRequired: external_exports.number(),
+      unacceptable: external_exports.number()
+    })
+  }),
+  gaps: external_exports.array(SnapshotGapSchema),
+  gapsSummary: external_exports.object({
+    errorCount: external_exports.number(),
+    warningCount: external_exports.number()
+  }),
+  riskTraceabilityChain: external_exports.array(SnapshotTraceabilityChainEntrySchema).optional(),
+  riskManagementPlan: SnapshotPlanReferenceSchema.optional(),
+  componentSnapshots: external_exports.record(external_exports.array(ComponentSnapshotEntryResponseSchema)).optional()
+});
+var DHRMarketEntryResponseSchema = external_exports.object({
+  country: external_exports.string(),
+  clinicalEvaluation: external_exports.boolean()
+});
+var DHRTestEvidenceEntryResponseSchema = external_exports.object({
+  label: external_exports.string(),
+  url: external_exports.string()
+});
+var DHRMetadataResponseSchema = external_exports.object({
+  markets: external_exports.array(DHRMarketEntryResponseSchema),
+  udi: external_exports.string().nullable(),
+  automatedTestEvidence: external_exports.array(DHRTestEvidenceEntryResponseSchema)
+});
+var DeploymentReferenceResponseSchema = external_exports.object({
+  label: external_exports.string(),
+  url: external_exports.string(),
+  type: external_exports.string()
+});
+var GateOverrideResponseSchema = external_exports.object({
+  category: external_exports.string(),
+  justification: external_exports.string(),
+  gapDocumentIds: external_exports.array(external_exports.string()),
+  gapCount: external_exports.number(),
+  createdBy: external_exports.string(),
+  createdByEmail: external_exports.string(),
+  createdByDepartment: external_exports.string(),
+  createdAt: external_exports.string()
+});
+var ReleaseChecklistItemResponseSchema = external_exports.object({
+  templateItemId: external_exports.string(),
+  label: external_exports.string(),
+  checked: external_exports.boolean(),
+  evidence: external_exports.string().optional(),
+  updatedBy: external_exports.string().optional(),
+  updatedAt: external_exports.string().optional()
+});
+var ReleaseDocumentManifestEntrySchema = external_exports.object({
+  documentId: external_exports.string(),
+  title: external_exports.string(),
+  type: external_exports.string(),
+  path: external_exports.string(),
+  commitSha: external_exports.string()
+});
+var ReleaseSummaryResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  name: external_exports.string(),
+  description: external_exports.string().optional(),
+  type: ReleaseTypeSchema,
+  deviceId: external_exports.string().optional(),
+  status: ReleaseStatusSchema,
+  changesCount: external_exports.number(),
+  signaturesCount: external_exports.number(),
+  obligationsSummary: SigningObligationsSummarySchema,
+  createdBy: external_exports.string(),
+  createdAt: external_exports.string(),
+  // ISO datetime
+  submittedForReviewAt: external_exports.string().optional(),
+  approvedAt: external_exports.string().optional(),
+  publishedAt: external_exports.string().optional(),
+  obligationsDerivedAt: external_exports.string().optional(),
+  obligationsDerivationVersion: external_exports.number().optional(),
+  obligationsInputHash: external_exports.string().optional(),
+  releasePlanDocumentId: external_exports.string().optional(),
+  designReviewId: external_exports.string().optional(),
+  releaseNotesDocumentId: external_exports.string().optional(),
+  deviationNotes: external_exports.string().optional(),
+  dhr: DHRMetadataResponseSchema.optional(),
+  version: external_exports.string().optional()
+});
+var ReleaseDetailResponseSchema = ReleaseSummaryResponseSchema.extend({
+  changes: external_exports.array(ReleaseChangeResponseSchema),
+  signingObligations: external_exports.array(SigningObligationResponseSchema),
+  signatures: external_exports.array(SignatureResponseSchema).optional(),
+  snapshot: ReleaseSnapshotResponseSchema.optional(),
+  checklist: external_exports.array(ReleaseChecklistItemResponseSchema).optional(),
+  releaseCommitSha: external_exports.string().optional(),
+  previousReleaseId: external_exports.string().optional(),
+  previousReleaseCommitSha: external_exports.string().optional(),
+  deploymentReferences: external_exports.array(DeploymentReferenceResponseSchema).optional(),
+  smokeTestEvidence: external_exports.array(external_exports.object({ label: external_exports.string(), url: external_exports.string() })).optional(),
+  gateOverrides: external_exports.array(GateOverrideResponseSchema).default([]),
+  documentManifest: external_exports.array(ReleaseDocumentManifestEntrySchema).optional()
+});
+var ListReleasesResponseSchema = external_exports.object({
+  releases: external_exports.array(ReleaseSummaryResponseSchema),
+  total: external_exports.number(),
+  limit: external_exports.number(),
+  offset: external_exports.number()
+});
+var GetSignaturesResponseSchema = external_exports.object({
+  signatures: external_exports.array(SignatureResponseSchema)
+});
+var ChangedDocumentResponseSchema = external_exports.object({
+  documentId: external_exports.string(),
+  repositoryId: external_exports.string(),
+  documentPath: external_exports.string(),
+  documentTitle: external_exports.string(),
+  documentType: external_exports.string(),
+  currentCommitSha: external_exports.string(),
+  previousCommitSha: external_exports.string().optional(),
+  changeType: ReleaseChangeTypeSchema
+});
+var GetChangedDocumentsResponseSchema = external_exports.object({
+  changes: external_exports.array(ChangedDocumentResponseSchema),
+  previousReleaseId: external_exports.string().optional(),
+  previousReleaseName: external_exports.string().optional()
+});
+var CreateReleaseResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  release: ReleaseDetailResponseSchema
+});
+var ReleaseStatusChangeResponseSchema = external_exports.object({
+  success: external_exports.boolean(),
+  release: ReleaseDetailResponseSchema
+});
+var AddSignatureResponseSchema = external_exports.object({
+  signature: SignatureResponseSchema,
+  releaseStatus: ReleaseStatusSchema,
+  isAutoApproved: external_exports.boolean()
+});
+var ComparisonChangeTypeSchema = external_exports.enum(["added", "modified", "removed", "unchanged"]);
+var GetReleaseComparisonQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  baseReleaseId: external_exports.string().min(1).optional()
+});
+var ComparisonReleaseInfoSchema = external_exports.object({
+  id: external_exports.string(),
+  name: external_exports.string(),
+  publishedAt: external_exports.string().nullable()
+});
+var ComparisonCommitRefSchema = external_exports.object({
+  commitSha: external_exports.string()
+});
+var ReleaseComparisonChangeSchema = external_exports.object({
+  documentId: external_exports.string(),
+  documentTitle: external_exports.string(),
+  documentType: external_exports.string(),
+  documentPath: external_exports.string(),
+  changeType: ComparisonChangeTypeSchema,
+  target: ComparisonCommitRefSchema.nullable(),
+  base: ComparisonCommitRefSchema.nullable()
+});
+var ComparisonSummarySchema = external_exports.object({
+  added: external_exports.number(),
+  modified: external_exports.number(),
+  removed: external_exports.number(),
+  unchanged: external_exports.number()
+});
+var BaselineOptionSchema = external_exports.object({
+  id: external_exports.string(),
+  name: external_exports.string(),
+  publishedAt: external_exports.string()
+});
+var ReleaseComparisonResponseSchema = external_exports.object({
+  targetRelease: ComparisonReleaseInfoSchema,
+  baseRelease: ComparisonReleaseInfoSchema.nullable(),
+  changes: external_exports.array(ReleaseComparisonChangeSchema),
+  summary: ComparisonSummarySchema,
+  fallback: external_exports.boolean(),
+  baselineOptions: external_exports.array(BaselineOptionSchema)
+});
+var CreateQmsRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  repositoryId: external_exports.string().min(1),
+  name: external_exports.string().min(1).max(100)
+});
+var UpdateQmsRequestSchema = external_exports.object({
+  name: external_exports.string().min(1).max(100).optional()
+});
+var QmsIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  qmsId: external_exports.string().min(1)
+});
+var QmsResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  organizationId: external_exports.string(),
+  repositoryId: external_exports.string(),
+  name: external_exports.string(),
+  createdAt: external_exports.string(),
+  createdBy: external_exports.string()
+});
+var CreateDeviceRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  repositoryId: external_exports.string().min(1),
+  name: external_exports.string().min(1).max(100),
+  safetyClass: SafetyClassSchema
+});
+var UpdateDeviceRequestSchema = external_exports.object({
+  name: external_exports.string().min(1).max(100).optional(),
+  safetyClass: SafetyClassSchema.optional()
+});
+var DeviceIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  deviceId: external_exports.string().min(1)
+});
+var DeviceListQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1)
+});
+var DeviceResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  organizationId: external_exports.string(),
+  repositoryId: external_exports.string(),
+  name: external_exports.string(),
+  safetyClass: SafetyClassSchema,
+  createdAt: external_exports.string(),
+  createdBy: external_exports.string()
+});
+var DocumentSignatureTypeSchema = external_exports.enum([
+  "author",
+  "reviewer",
+  "approver",
+  "dept_reviewer",
+  "final_approver",
+  "trainee",
+  "trainer"
+]);
+var SignatureCaptureContextSchema = external_exports.discriminatedUnion("type", [
+  external_exports.object({
+    type: external_exports.literal("release"),
+    id: external_exports.string().min(1)
+  }),
+  external_exports.object({
+    type: external_exports.literal("design_review"),
+    id: external_exports.string().min(1)
+  }),
+  external_exports.object({
+    type: external_exports.literal("dco"),
+    id: external_exports.string().min(1)
+  }),
+  external_exports.object({
+    type: external_exports.literal("document_signoff"),
+    id: external_exports.string().min(1)
+  }),
+  external_exports.object({
+    type: external_exports.literal("nonconformance"),
+    id: external_exports.string().min(1)
+  }),
+  external_exports.object({
+    type: external_exports.literal("complaint"),
+    id: external_exports.string().min(1)
+  }),
+  external_exports.object({
+    type: external_exports.literal("training_completion"),
+    id: external_exports.string().min(1)
+  }),
+  external_exports.object({
+    type: external_exports.literal("training_signoff"),
+    id: external_exports.string().min(1)
+  })
+]);
+var CreateDocumentSignatureRequestSchema = external_exports.object({
+  signatureType: DocumentSignatureTypeSchema,
+  meaning: external_exports.string().min(1).max(500),
+  capturedDuring: SignatureCaptureContextSchema,
+  reason: external_exports.string().max(500).optional(),
+  /** Fresh Firebase ID token for per-signature re-authentication (Part 11 §11.200) */
+  idToken: external_exports.string().min(1).optional(),
+  /** Part 11: ID of the ERSD version the signer accepted */
+  ersdDisclosureId: external_exports.string().min(1),
+  /** Part 11: ISO date string when the signer accepted the ERSD */
+  ersdAcceptedAt: external_exports.string().datetime()
+});
+var SignatureDocumentCommitParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  docId: external_exports.string().min(1),
+  commitSha: external_exports.string().min(1)
+});
+var SignatureDocumentIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  docId: external_exports.string().min(1)
+});
+var DocumentSignatureResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  organizationId: external_exports.string(),
+  documentId: external_exports.string(),
+  commitSha: external_exports.string(),
+  userId: external_exports.string(),
+  userEmail: external_exports.string(),
+  userDisplayName: external_exports.string(),
+  userDepartment: external_exports.string(),
+  signatureType: DocumentSignatureTypeSchema,
+  meaning: external_exports.string(),
+  contentHash: external_exports.string().optional(),
+  timestamp: external_exports.string(),
+  capturedDuring: SignatureCaptureContextSchema
+});
+var DocumentSignaturesListResponseSchema = external_exports.object({
+  signatures: external_exports.array(DocumentSignatureResponseSchema)
+});
+var DocumentSignatureHistoryItemSchema = external_exports.object({
+  commitSha: external_exports.string(),
+  signatures: external_exports.array(DocumentSignatureResponseSchema)
+});
+var DocumentSignatureHistoryResponseSchema = external_exports.object({
+  documentId: external_exports.string(),
+  history: external_exports.array(DocumentSignatureHistoryItemSchema)
+});
+var CreateDocumentSignatureResponseSchema = external_exports.object({
+  signatureId: external_exports.string()
+});
+var GitHubCommitAuthorSchema = external_exports.object({
+  email: external_exports.string(),
+  name: external_exports.string()
+});
+var GitHubPushCommitSchema = external_exports.object({
+  id: external_exports.string(),
+  message: external_exports.string(),
+  author: GitHubCommitAuthorSchema,
+  added: external_exports.array(external_exports.string()),
+  modified: external_exports.array(external_exports.string()),
+  removed: external_exports.array(external_exports.string())
+});
+var GitHubWebhookRepositorySchema = external_exports.object({
+  id: external_exports.number(),
+  full_name: external_exports.string()
+});
+var GitHubInstallationSchema = external_exports.object({
+  id: external_exports.number()
+});
+var GitHubAccountSchema = external_exports.object({
+  login: external_exports.string(),
+  type: external_exports.string()
+});
+var GitHubPushEventSchema = external_exports.object({
+  ref: external_exports.string(),
+  before: external_exports.string(),
+  after: external_exports.string(),
+  repository: GitHubWebhookRepositorySchema,
+  installation: GitHubInstallationSchema.optional(),
+  commits: external_exports.array(GitHubPushCommitSchema)
+});
+var GitHubInstallationEventSchema = external_exports.object({
+  action: external_exports.enum(["created", "deleted", "suspend", "unsuspend"]),
+  installation: external_exports.object({
+    id: external_exports.number(),
+    account: GitHubAccountSchema
+  }),
+  repositories: external_exports.array(
+    external_exports.object({
+      id: external_exports.number(),
+      full_name: external_exports.string()
+    })
+  ).optional()
+});
+var GitHubInstallationRepositoriesEventSchema = external_exports.object({
+  action: external_exports.enum(["added", "removed"]),
+  installation: external_exports.object({
+    id: external_exports.number(),
+    account: GitHubAccountSchema
+  }),
+  repositories_added: external_exports.array(
+    external_exports.object({
+      id: external_exports.number(),
+      full_name: external_exports.string()
+    })
+  ),
+  repositories_removed: external_exports.array(
+    external_exports.object({
+      id: external_exports.number(),
+      full_name: external_exports.string()
+    })
+  )
+});
+var GitHubWebhookHeadersSchema = external_exports.object({
+  "x-github-event": external_exports.string(),
+  "x-github-delivery": external_exports.string(),
+  "x-hub-signature-256": external_exports.string().optional()
+});
+var CompleteGitHubInstallationRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  installationId: external_exports.number().int().positive()
+});
+var ListGitHubRepositoriesRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1)
+});
+var GitHubInstallationRepoSchema = external_exports.object({
+  id: external_exports.number(),
+  full_name: external_exports.string(),
+  name: external_exports.string(),
+  owner: external_exports.string(),
+  default_branch: external_exports.string()
+});
+var ListGitHubRepositoriesResponseSchema = external_exports.object({
+  repositories: external_exports.array(GitHubInstallationRepoSchema),
+  installed: external_exports.boolean(),
+  gitHubOrgName: external_exports.string().optional()
+});
+var CompleteGitHubInstallationResponseSchema = external_exports.object({
+  success: external_exports.boolean()
+});
+var TrainingTypeSchema = external_exports.enum(["quiz", "acknowledge", "instructor_led"]);
+var TrainingStatusSchema = external_exports.enum(["pending", "in_progress", "completed", "overdue"]);
+var TrainingOrgParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1)
+});
+var TrainingTaskParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  taskId: external_exports.string().min(1)
+});
+var MyTrainingQuerySchema = external_exports.object({
+  status: TrainingStatusSchema.optional(),
+  documentId: external_exports.string().optional()
+});
+var TrainingDashboardQuerySchema = external_exports.object({
+  status: TrainingStatusSchema.optional(),
+  memberId: external_exports.string().optional(),
+  documentId: external_exports.string().optional()
+});
+var StartTrainingRequestSchema = external_exports.object({});
+var SubmitQuizRequestSchema = external_exports.object({
+  sessionId: external_exports.string().min(1),
+  answers: external_exports.record(external_exports.string(), external_exports.union([external_exports.number(), external_exports.array(external_exports.number()), external_exports.boolean()]))
+});
+var AcknowledgeTrainingRequestSchema = external_exports.object({
+  meaning: external_exports.string().min(1).max(500)
+});
+var BatchSignoffRequestSchema = external_exports.object({
+  taskIds: external_exports.array(external_exports.string().min(1)).min(1),
+  evidenceUrl: external_exports.string().url(),
+  evidenceHash: external_exports.string().min(1),
+  meaning: external_exports.string().min(1).max(500)
+});
+var QuizOptionSchema = external_exports.object({
+  text: external_exports.string().min(1),
+  correct: external_exports.boolean().optional(),
+  explanation: external_exports.string().optional()
+});
+var QuizQuestionSchema = external_exports.object({
+  type: external_exports.enum(["single-choice", "multi-choice", "true-false"]),
+  text: external_exports.string().min(1),
+  options: external_exports.array(QuizOptionSchema).optional(),
+  correct: external_exports.boolean().optional(),
+  explanation: external_exports.string().optional()
+});
+var QuizDefinitionSchema = external_exports.object({
+  passingScore: external_exports.number().min(0).max(100).optional(),
+  questions: external_exports.array(QuizQuestionSchema).min(1)
+});
+var CreateTrainingTaskRequestSchema = external_exports.object({
+  memberId: external_exports.string().min(1),
+  documentId: external_exports.string().min(1),
+  documentVersion: external_exports.string().min(1),
+  trainingType: TrainingTypeSchema,
+  dueDays: external_exports.number().int().positive().optional(),
+  /** Required for quiz-type training. Stored server-side for scoring. */
+  quizDefinition: QuizDefinitionSchema.optional()
+});
+var UpdateTrainingSettingsRequestSchema = external_exports.object({
+  defaultDueDays: external_exports.number().int().positive().optional(),
+  passingScorePercent: external_exports.number().int().min(0).max(100).optional()
+});
+var BulkAssignTrainingRequestSchema = external_exports.object({
+  department: external_exports.string().min(1),
+  documentId: external_exports.string().min(1),
+  documentVersion: external_exports.string().min(1),
+  trainingType: TrainingTypeSchema,
+  dueDays: external_exports.number().int().positive().optional()
+});
+var TrainingTaskResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  organizationId: external_exports.string(),
+  memberId: external_exports.string(),
+  memberName: external_exports.string(),
+  memberEmail: external_exports.string(),
+  documentId: external_exports.string(),
+  documentTitle: external_exports.string(),
+  documentVersion: external_exports.string(),
+  trainingType: TrainingTypeSchema,
+  status: TrainingStatusSchema,
+  dueDate: external_exports.string(),
+  createdAt: external_exports.string(),
+  startedAt: external_exports.string().optional(),
+  completedAt: external_exports.string().optional(),
+  quizScore: external_exports.number().optional(),
+  signatureId: external_exports.string().optional(),
+  evidenceUrl: external_exports.string().optional()
+});
+var QuizOptionResponseSchema = external_exports.object({
+  text: external_exports.string()
+});
+var QuizQuestionTypeSchema = external_exports.enum(["single_choice", "multiple_choice", "true_false"]);
+var QuizQuestionResponseSchema = external_exports.object({
+  type: QuizQuestionTypeSchema,
+  text: external_exports.string(),
+  options: external_exports.array(QuizOptionResponseSchema).optional()
+});
+var QuizSessionResponseSchema = external_exports.object({
+  sessionId: external_exports.string(),
+  questions: external_exports.array(QuizQuestionResponseSchema),
+  questionCount: external_exports.number(),
+  passingScore: external_exports.number(),
+  savedAnswers: external_exports.record(external_exports.string(), external_exports.union([external_exports.number(), external_exports.array(external_exports.number()), external_exports.boolean()])).optional()
+});
+var QuizResultResponseSchema = external_exports.object({
+  passed: external_exports.boolean(),
+  score: external_exports.number(),
+  passingScore: external_exports.number(),
+  correctCount: external_exports.number(),
+  totalCount: external_exports.number(),
+  explanations: external_exports.record(external_exports.string(), external_exports.string()),
+  signatureRequired: external_exports.boolean()
+});
+var TrainingStatsResponseSchema = external_exports.object({
+  pending: external_exports.number(),
+  inProgress: external_exports.number(),
+  completed: external_exports.number(),
+  overdue: external_exports.number(),
+  completionRate: external_exports.number()
+});
+var TrainingDashboardResponseSchema = external_exports.object({
+  stats: TrainingStatsResponseSchema,
+  tasks: external_exports.array(TrainingTaskResponseSchema)
+});
+var TrainingSettingsResponseSchema = external_exports.object({
+  defaultDueDays: external_exports.number(),
+  passingScorePercent: external_exports.number()
+});
+var BulkAssignTrainingResponseSchema = external_exports.object({
+  createdCount: external_exports.number(),
+  skippedCount: external_exports.number(),
+  memberNames: external_exports.array(external_exports.string())
+});
+var SigningEligibilityResponseSchema = external_exports.object({
+  eligible: external_exports.boolean(),
+  hasIncompleteTraining: external_exports.boolean()
+});
+var SigningRequestStatusSchema = external_exports.enum([
+  "sent",
+  "partially_signed",
+  "completed",
+  "expired",
+  "cancelled"
+]);
+var SignerStatusSchema = external_exports.enum(["pending", "viewed", "signed", "declined"]);
+var FieldTypeSchema = external_exports.enum(["signature", "initials", "date"]);
+var SigningFieldSchema = external_exports.object({
+  id: external_exports.string().min(1),
+  type: FieldTypeSchema,
+  assignedSignerEmail: external_exports.string().email(),
+  /** 1-based page index within the PDF document. */
+  page: external_exports.number().int().positive(),
+  /** Field left edge as a percentage of the page width (0–100). */
+  x: external_exports.number().min(0).max(100),
+  /** Field top edge as a percentage of the page height (0–100). */
+  y: external_exports.number().min(0).max(100),
+  /** Field width as a percentage of the page width (0–100). */
+  width: external_exports.number().min(0).max(100),
+  /** Field height as a percentage of the page height (0–100). */
+  height: external_exports.number().min(0).max(100)
+});
+var SigningDocumentInputSchema = external_exports.object({
+  fileName: external_exports.string().min(1),
+  storagePath: external_exports.string().startsWith("signing-uploads/"),
+  fileHash: external_exports.string().min(1),
+  pageCount: external_exports.number().int().positive(),
+  fields: external_exports.array(SigningFieldSchema).min(1)
+});
+var SignerInputSchema = external_exports.object({
+  name: external_exports.string().min(1).max(200),
+  email: external_exports.string().email(),
+  meaning: external_exports.string().min(1).max(500)
+});
+var SigningRequestIdParamSchema = external_exports.object({
+  signingRequestId: external_exports.string().min(1)
+});
+var ListSigningRequestsQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  status: SigningRequestStatusSchema.optional(),
+  limit: external_exports.coerce.number().int().positive().max(100).default(50),
+  offset: external_exports.coerce.number().int().nonnegative().default(0)
+});
+var GetSigningRequestQuerySchema = external_exports.object({
+  organizationId: external_exports.string().min(1)
+});
+var CreateSigningRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1),
+  title: external_exports.string().min(1).max(200),
+  description: external_exports.string().max(2e3).optional(),
+  meaning: external_exports.string().min(1).max(500),
+  expiresAt: external_exports.string().datetime(),
+  signingDocuments: external_exports.array(SigningDocumentInputSchema).min(1),
+  signers: external_exports.array(SignerInputSchema).min(1)
+});
+var CancelSigningRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1)
+});
+var RemindSignersSchema = external_exports.object({
+  organizationId: external_exports.string().min(1)
+});
+var GetSigningCeremonyParamSchema = external_exports.object({
+  token: external_exports.string().min(1)
+});
+var RequestVerificationCodeSchema = external_exports.object({
+  token: external_exports.string().min(1)
+});
+var CompleteSigningCeremonySchema = external_exports.object({
+  token: external_exports.string().min(1),
+  verificationCode: external_exports.string().length(6),
+  signatureImagePath: external_exports.string().startsWith("data:"),
+  initialsImagePath: external_exports.string().startsWith("data:").optional(),
+  fieldValues: external_exports.array(
+    external_exports.object({
+      fieldId: external_exports.string().min(1),
+      type: FieldTypeSchema,
+      value: external_exports.string().min(1).refine((v) => v.startsWith("data:") || /^\d{4}-\d{2}-\d{2}/.test(v), {
+        message: "Value must be a data URL or a date string"
+      })
+    })
+  ).min(1),
+  /** Part 11: ID of the ERSD version the signer accepted — required, 400 if missing */
+  ersdDisclosureId: external_exports.string().min(1),
+  /** Part 11: ISO timestamp when the signer accepted the ERSD — required, 400 if missing */
+  ersdAcceptedAt: external_exports.string().datetime()
+});
+var SigningFieldResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  type: FieldTypeSchema,
+  assignedSignerEmail: external_exports.string(),
+  page: external_exports.number(),
+  x: external_exports.number(),
+  y: external_exports.number(),
+  width: external_exports.number(),
+  height: external_exports.number()
+});
+var SigningDocumentResponseSchema = external_exports.object({
+  fileName: external_exports.string(),
+  storagePath: external_exports.string(),
+  fileHash: external_exports.string(),
+  pageCount: external_exports.number(),
+  uploadedAt: external_exports.string(),
+  fields: external_exports.array(SigningFieldResponseSchema)
+});
+var SignerResponseSchema = external_exports.object({
+  name: external_exports.string(),
+  email: external_exports.string(),
+  meaning: external_exports.string(),
+  status: SignerStatusSchema,
+  signedAt: external_exports.string().optional()
+});
+var SigningAuditEntryResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  eventType: external_exports.string(),
+  actor: external_exports.string(),
+  timestamp: external_exports.string(),
+  details: external_exports.record(external_exports.unknown()).optional()
+});
+var SigningRequestSummaryResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  title: external_exports.string(),
+  status: SigningRequestStatusSchema,
+  meaning: external_exports.string(),
+  signerCount: external_exports.number(),
+  signedCount: external_exports.number(),
+  createdAt: external_exports.string(),
+  expiresAt: external_exports.string()
+});
+var SigningRequestDetailResponseSchema = SigningRequestSummaryResponseSchema.extend({
+  description: external_exports.string().optional(),
+  createdBy: external_exports.string(),
+  createdByEmail: external_exports.string(),
+  signingDocuments: external_exports.array(SigningDocumentResponseSchema),
+  signers: external_exports.array(SignerResponseSchema),
+  auditTrail: external_exports.array(SigningAuditEntryResponseSchema)
+});
+var ListSigningRequestsResponseSchema = external_exports.object({
+  signingRequests: external_exports.array(SigningRequestSummaryResponseSchema),
+  total: external_exports.number()
+});
+var CeremonyDocumentResponseSchema = SigningDocumentResponseSchema.omit({
+  storagePath: true
+});
+var CeremonyERSDResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  content: external_exports.string(),
+  version: external_exports.string()
+});
+var SigningCeremonyResponseSchema = external_exports.object({
+  organizationName: external_exports.string(),
+  title: external_exports.string(),
+  description: external_exports.string().optional(),
+  meaning: external_exports.string(),
+  signerName: external_exports.string(),
+  signerEmail: external_exports.string(),
+  status: external_exports.enum(["ready", "already_signed", "expired", "cancelled"]),
+  signingDocuments: external_exports.array(CeremonyDocumentResponseSchema),
+  /** Only fields assigned to this signer */
+  fields: external_exports.array(SigningFieldResponseSchema),
+  /** Part 11: Electronic Record and Signature Disclosure — must be accepted before signing */
+  ersd: CeremonyERSDResponseSchema
+});
+var DownloadSignedPdfResponseSchema = external_exports.object({
+  downloadUrl: external_exports.string().url()
+});
+var NotificationTypeSchema = external_exports.enum([
+  "training_assigned",
+  "training_overdue",
+  "release_submitted_for_review",
+  "release_published",
+  "signature_requested",
+  "capa_overdue",
+  "nc_overdue",
+  "complaint_overdue",
+  "action_overdue",
+  "objective_threshold_breach",
+  "review_due_soon",
+  "review_auto_drafted",
+  "review_overdue"
+]);
+var NotificationOrgParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1)
+});
+var NotificationIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  notificationId: external_exports.string().min(1)
+});
+var NotificationQuerySchema = external_exports.object({
+  unreadOnly: external_exports.enum(["true", "false"]).optional(),
+  type: NotificationTypeSchema.optional(),
+  limit: external_exports.coerce.number().int().positive().max(100).optional()
+});
+var NotificationResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  type: NotificationTypeSchema,
+  title: external_exports.string(),
+  body: external_exports.string(),
+  resourceType: external_exports.string(),
+  resourceId: external_exports.string(),
+  deepLink: external_exports.string(),
+  read: external_exports.boolean(),
+  createdAt: external_exports.string()
+});
+var NotificationListResponseSchema = external_exports.object({
+  notifications: external_exports.array(NotificationResponseSchema),
+  unreadCount: external_exports.number()
+});
+var CreateCheckoutSessionRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1)
+});
+var CreatePortalSessionRequestSchema = external_exports.object({
+  organizationId: external_exports.string().min(1)
+});
+var MonthlyCountSchema = external_exports.object({
+  month: external_exports.string(),
+  // 'YYYY-MM'
+  opened: external_exports.number(),
+  closed: external_exports.number()
+});
+var CapaMetricsSchema = external_exports.object({
+  total: external_exports.number(),
+  byStatus: external_exports.record(external_exports.string(), external_exports.number()),
+  overdue: external_exports.number(),
+  avgCycleTimeDays: external_exports.number().nullable(),
+  trend: external_exports.array(MonthlyCountSchema)
+});
+var NcMetricsSchema = external_exports.object({
+  total: external_exports.number(),
+  byStatus: external_exports.record(external_exports.string(), external_exports.number()),
+  bySeverity: external_exports.record(external_exports.string(), external_exports.number()),
+  overdue: external_exports.number(),
+  avgCycleTimeDays: external_exports.number().nullable(),
+  trend: external_exports.array(MonthlyCountSchema)
+});
+var ComplaintMetricsSchema = external_exports.object({
+  total: external_exports.number(),
+  byStatus: external_exports.record(external_exports.string(), external_exports.number()),
+  bySeverity: external_exports.record(external_exports.string(), external_exports.number()),
+  overdue: external_exports.number(),
+  reportableCount: external_exports.number(),
+  avgCycleTimeDays: external_exports.number().nullable(),
+  trend: external_exports.array(MonthlyCountSchema)
+});
+var TrainingMetricsSchema = external_exports.object({
+  totalTasks: external_exports.number(),
+  complianceRate: external_exports.number(),
+  // 0-100
+  byStatus: external_exports.record(external_exports.string(), external_exports.number()),
+  overdue: external_exports.number()
+});
+var ReleaseMetricsSchema = external_exports.object({
+  total: external_exports.number(),
+  byStatus: external_exports.record(external_exports.string(), external_exports.number()),
+  avgCycleTimeDays: external_exports.number().nullable()
+});
+var AuditMetricsSchema = external_exports.object({
+  totalSchedules: external_exports.number(),
+  totalReports: external_exports.number(),
+  findingsMajor: external_exports.number(),
+  findingsMinor: external_exports.number(),
+  findingsObservations: external_exports.number()
+});
+var QualityMetricsResponseSchema = external_exports.object({
+  generatedAt: external_exports.string(),
+  period: external_exports.object({
+    from: external_exports.string(),
+    to: external_exports.string()
+  }),
+  capas: CapaMetricsSchema,
+  nonconformances: NcMetricsSchema,
+  complaints: ComplaintMetricsSchema,
+  training: TrainingMetricsSchema,
+  releases: ReleaseMetricsSchema,
+  audits: AuditMetricsSchema
+});
+var QualityMetricsQuerySchema = external_exports.object({
+  period: external_exports.enum(["30d", "90d", "365d"]).optional().default("90d")
+});
+var ApiKeyOrgParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1)
+});
+var ApiKeyIdParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  apiKeyId: external_exports.string().min(1)
+});
+var CreateApiKeyRequestSchema = external_exports.object({
+  name: external_exports.string().min(1).max(100)
+});
+var ApiKeyResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  name: external_exports.string(),
+  prefix: external_exports.string(),
+  createdAt: external_exports.string(),
+  lastUsedAt: external_exports.string().nullable(),
+  createdBy: external_exports.string(),
+  createdByEmail: external_exports.string()
+});
+var CreateApiKeyResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  name: external_exports.string(),
+  key: external_exports.string(),
+  prefix: external_exports.string(),
+  createdAt: external_exports.string()
+});
+var ApiKeyListResponseSchema = external_exports.object({
+  keys: external_exports.array(ApiKeyResponseSchema)
+});
+var CompliancePackageStatusEnum = external_exports.enum([
+  "pending",
+  "in_progress",
+  "completed",
+  "failed"
+]);
+var CompliancePackageSectionEnum = external_exports.enum([
+  "system_description",
+  "electronic_signatures",
+  "audit_trails",
+  "access_controls",
+  "change_control",
+  "dhr_attestation",
+  "compiled_documents"
+]);
+var ComplianceOrgParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1)
+});
+var CompliancePackageParamSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  packageId: external_exports.string().min(1)
+});
+var GenerateCompliancePackageRequestSchema = external_exports.object({
+  /** Safety class determines which sections and depth of evidence to include */
+  safetyClass: SafetyClassSchema,
+  /** Sections to include; defaults to all if omitted */
+  sections: external_exports.array(CompliancePackageSectionEnum).min(1).optional(),
+  /** Optional date range filter for audit trail entries */
+  auditTrailFrom: external_exports.string().datetime().optional(),
+  auditTrailTo: external_exports.string().datetime().optional(),
+  /** Optional release ID to scope signatures and change control to a specific release */
+  releaseId: external_exports.string().optional()
+});
+var CompliancePackageResponseSchema = external_exports.object({
+  id: external_exports.string(),
+  organizationId: external_exports.string(),
+  status: CompliancePackageStatusEnum,
+  safetyClass: SafetyClassSchema,
+  sections: external_exports.array(CompliancePackageSectionEnum),
+  /** Requesting member info */
+  requestedById: external_exports.string(),
+  requestedByName: external_exports.string(),
+  requestedAt: external_exports.string(),
+  /** Completion timestamps */
+  completedAt: external_exports.string().optional(),
+  /** Expiry for the download URL */
+  downloadExpiresAt: external_exports.string().optional(),
+  /** Error message — only present when status is 'failed' */
+  errorMessage: external_exports.string().optional(),
+  /** Optional scoping filters used during generation */
+  releaseId: external_exports.string().optional(),
+  auditTrailFrom: external_exports.string().optional(),
+  auditTrailTo: external_exports.string().optional()
+});
+var CompliancePackageListResponseSchema = external_exports.object({
+  packages: external_exports.array(CompliancePackageResponseSchema)
+});
+var ValidationPackageResponseSchema = external_exports.object({
+  downloadUrl: external_exports.string().url(),
+  version: external_exports.string(),
+  lastUpdated: external_exports.string()
+});
+var ReadinessSeveritySchema = external_exports.enum(["error", "warning", "info"]);
+var ReadinessItemSchema = external_exports.object({
+  severity: ReadinessSeveritySchema,
+  message: external_exports.string(),
+  documentId: external_exports.string().optional(),
+  releaseId: external_exports.string().optional(),
+  action: external_exports.string()
+});
+var ReadinessDimensionSchema = external_exports.object({
+  name: external_exports.string(),
+  score: external_exports.number().min(0).max(100),
+  weight: external_exports.number().min(0).max(1),
+  details: external_exports.string(),
+  items: external_exports.array(ReadinessItemSchema)
+});
+var ComplianceReadinessResponseSchema = external_exports.object({
+  overallScore: external_exports.number().min(0).max(100),
+  calculatedAt: external_exports.string(),
+  dimensions: external_exports.array(ReadinessDimensionSchema)
+});
+var QUALITY_FINDING_CODES = [
+  "review_overdue",
+  "action_overdue",
+  "objective_off_target",
+  "review_actions_incomplete"
 ];
-var DOCUMENT_TYPES = {
-  user_need: "User Need",
-  requirement: "Requirement",
-  architecture: "Architecture",
-  detailed_design: "Detailed Design",
-  test_protocol: "Test Protocol",
-  test_report: "Test Report",
-  sop: "SOP",
-  work_instruction: "Work Instruction",
-  policy: "Policy",
-  usability_risk: "Usability Risk",
-  software_risk: "Software Risk",
-  security_risk: "Security Risk",
-  // Risk document types
-  haz_soe_software: "Hazard (Software)",
-  haz_soe_security: "Hazard (Security)",
-  hazardous_situation: "Hazardous Situation",
-  harm: "Harm",
-  hazard_category: "Hazard Category",
-  // Usability engineering (IEC 62366)
-  usability_plan: "Usability Plan",
-  use_specification: "Use Specification",
-  task_analysis: "Task Analysis",
-  usability_evaluation: "Usability Evaluation",
-  summative_evaluation: "Summative Evaluation",
-  // Risk management (ISO 14971)
-  risk_management_plan: "Risk Management Plan",
-  // Software lifecycle (IEC 62304)
-  software_development_plan: "Software Development Plan",
-  software_maintenance_plan: "Software Maintenance Plan",
-  soup_register: "SOUP Register",
-  // Problem resolution (IEC 62304 §9)
-  anomaly: "Anomaly",
-  // Cybersecurity (IEC 81001-5-1)
-  cybersecurity_plan: "Cybersecurity Plan",
-  sbom: "SBOM",
-  // Clinical (MDR / FDA)
-  clinical_evaluation_plan: "Clinical Evaluation Plan",
-  clinical_evaluation_report: "Clinical Evaluation Report",
-  // Post-market surveillance (MDR Art. 83)
-  post_market_surveillance_plan: "Post-Market Surveillance Plan",
-  post_market_feedback: "Post-Market Feedback",
-  // Labeling (MDR Annex I)
-  labeling: "Labeling",
-  // Product (ISO 13485 §7.3)
-  product_development_plan: "Product Development Plan",
-  intended_use: "Intended Use",
-  // Release management (IEC 62304 §5.7)
-  release_plan: "Release Plan",
-  // Change management (ISO 13485 §7.3.5)
-  design_review: "Design Review",
-  release_notes: "Release Notes",
-  // Supplier management (ISO 13485 §7.4)
-  supplier: "Supplier",
-  // Internal audit management (ISO 13485 §8.2.2)
-  audit_schedule: "Audit Schedule",
-  audit_report: "Audit Report",
-  // Management review (ISO 13485 §5.6)
-  management_review: "Management Review",
-  // Software test plan (IEC 62304 §5.7)
-  software_test_plan: "Software Test Plan"
-};
-var LINK_TYPES = {
-  derives_from: "Derives From",
-  implements: "Implements",
-  verified_by: "Verified By",
-  mitigates: "Mitigates",
-  parent_of: "Parent Of",
-  related_to: "Related To",
-  // New risk link types
-  leads_to: "Leads To",
-  results_in: "Results In",
-  analyzes: "Analyzes"
-};
-var REQUIRED_SECTIONS = {
-  user_need: ["Purpose", "Stakeholder", "User Needs"],
-  architecture: ["Purpose"],
-  release_plan: ["Scope", "Applicable Plans", "Release-Specific Criteria", "Known Anomalies"],
-  design_review: ["Review Scope", "Attendees", "Findings", "Actions", "Conclusion"],
-  release_notes: ["Changes", "Known Issues"],
-  audit_schedule: ["Scope", "Audit Criteria"],
-  audit_report: ["Scope", "Methodology", "Findings", "Conclusion"],
-  management_review: ["Review Inputs", "Review Outputs", "Action Items", "Decisions"],
-  hazard_category: ["Description", "Examples", "Applicable Standards"]
-};
-var MemberPermissionsSchema = external_exports.object({
-  canSign: external_exports.boolean(),
-  canApprove: external_exports.boolean(),
-  canCreateRelease: external_exports.boolean(),
-  canPublishRelease: external_exports.boolean(),
-  canManageMembers: external_exports.boolean(),
-  canViewAuditLog: external_exports.boolean(),
-  canExport: external_exports.boolean()
+var QUALITY_FINDING_SEVERITIES = ["error", "warning"];
+var QualityFindingSchema = external_exports.object({
+  code: external_exports.enum(QUALITY_FINDING_CODES),
+  severity: external_exports.enum(QUALITY_FINDING_SEVERITIES),
+  entityId: external_exports.string(),
+  entityTitle: external_exports.string(),
+  message: external_exports.string(),
+  metadata: external_exports.record(external_exports.unknown()).optional()
+});
+var QualityFindingsResponseSchema = external_exports.object({
+  findings: external_exports.array(QualityFindingSchema),
+  summary: external_exports.object({
+    errorCount: external_exports.number(),
+    warningCount: external_exports.number(),
+    overdueActions: external_exports.number(),
+    overdueReviews: external_exports.number(),
+    offTargetObjectives: external_exports.number(),
+    incompleteReviewActions: external_exports.number()
+  })
+});
+var GetFrameworksQuerySchema = external_exports.object({
+  scope: FrameworkScopeSchema.optional()
+});
+var GetFrameworkParamsSchema = external_exports.object({
+  frameworkId: RegulatoryFrameworkSchema
+});
+var GetClauseMappingsParamsSchema = external_exports.object({
+  frameworkId: RegulatoryFrameworkSchema,
+  clauseId: external_exports.string().min(1)
+});
+var GetCrosswalkQuerySchema = external_exports.object({
+  targetFrameworkId: RegulatoryFrameworkSchema
+});
+var GetQmsComplianceParamsSchema = external_exports.object({
+  orgId: external_exports.string().min(1)
+});
+var GetQmsComplianceQuerySchema = external_exports.object({
+  repositoryId: external_exports.string().min(1)
+});
+var GetDeviceComplianceParamsSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  deviceId: external_exports.string().min(1)
+});
+var GetDeviceFrameworkComplianceParamsSchema = external_exports.object({
+  orgId: external_exports.string().min(1),
+  deviceId: external_exports.string().min(1),
+  frameworkId: RegulatoryFrameworkSchema
+});
+var FrameworkSummarySchema = external_exports.object({
+  id: RegulatoryFrameworkSchema,
+  name: external_exports.string(),
+  version: external_exports.string(),
+  scope: FrameworkScopeSchema,
+  url: external_exports.string().nullable(),
+  active: external_exports.boolean(),
+  clauseCount: external_exports.number().int().nonnegative()
+});
+var FrameworksListResponseSchema = external_exports.object({
+  frameworks: external_exports.array(FrameworkSummarySchema)
+});
+var ClauseNodeSchema = external_exports.lazy(
+  () => external_exports.object({
+    id: external_exports.string(),
+    frameworkId: RegulatoryFrameworkSchema,
+    clauseNumber: external_exports.string(),
+    title: external_exports.string(),
+    parentClauseId: external_exports.string().nullable(),
+    depth: external_exports.number().int().nonnegative(),
+    sortOrder: external_exports.number().int().nonnegative(),
+    children: external_exports.array(ClauseNodeSchema)
+  })
+);
+var FrameworkDetailResponseSchema = external_exports.object({
+  id: RegulatoryFrameworkSchema,
+  name: external_exports.string(),
+  version: external_exports.string(),
+  scope: FrameworkScopeSchema,
+  url: external_exports.string().nullable(),
+  active: external_exports.boolean(),
+  clauses: external_exports.array(ClauseNodeSchema)
+});
+var ClauseMappingSchema = external_exports.object({
+  clauseId: external_exports.string(),
+  mappedFrameworkId: RegulatoryFrameworkSchema,
+  mappedFrameworkName: external_exports.string(),
+  mappedClauseId: external_exports.string(),
+  mappedClauseTitle: external_exports.string(),
+  relationship: MappingRelationshipSchema,
+  notes: external_exports.string().nullable()
+});
+var ClauseMappingsResponseSchema = external_exports.object({
+  clauseId: external_exports.string(),
+  frameworkId: RegulatoryFrameworkSchema,
+  mappings: external_exports.array(ClauseMappingSchema)
+});
+var CrosswalkResponseSchema = external_exports.object({
+  sourceFrameworkId: RegulatoryFrameworkSchema,
+  targetFrameworkId: RegulatoryFrameworkSchema,
+  mappings: external_exports.array(ClauseMappingSchema)
+});
+var FrameworkCoverageSchema = external_exports.object({
+  frameworkId: RegulatoryFrameworkSchema,
+  frameworkName: external_exports.string(),
+  totalClauses: external_exports.number().int().nonnegative(),
+  coveredClauses: external_exports.number().int().nonnegative(),
+  coveragePercent: external_exports.number().min(0).max(100),
+  scope: FrameworkScopeSchema
+});
+var ComplianceSummaryResponseSchema = external_exports.object({
+  organizationId: external_exports.string(),
+  frameworks: external_exports.array(FrameworkCoverageSchema),
+  overallCoveragePercent: external_exports.number().min(0).max(100)
+});
+var EvidenceItemSchema = external_exports.object({
+  documentId: external_exports.string(),
+  documentTitle: external_exports.string(),
+  /** Document type. Optional — omitted for non-document evidence (e.g. training records). */
+  docType: DocumentTypeSchema.optional(),
+  linkType: LinkTypeSchema.optional(),
+  status: external_exports.string()
+});
+var ClauseComplianceSchema = external_exports.object({
+  clauseId: external_exports.string(),
+  clauseNumber: external_exports.string(),
+  clauseTitle: external_exports.string(),
+  covered: external_exports.boolean(),
+  /** Compliance score 0..1 based on weighted evidence rules */
+  score: external_exports.number().min(0).max(1),
+  evidence: external_exports.array(EvidenceItemSchema)
+});
+var FrameworkComplianceResponseSchema = external_exports.object({
+  frameworkId: RegulatoryFrameworkSchema,
+  frameworkName: external_exports.string(),
+  totalClauses: external_exports.number().int().nonnegative(),
+  coveredClauses: external_exports.number().int().nonnegative(),
+  coveragePercent: external_exports.number().min(0).max(100),
+  clauses: external_exports.array(ClauseComplianceSchema)
+});
+var ClauseEvidenceStatusSchema = external_exports.enum(["covered", "partial", "missing"]);
+var ClauseEvidenceItemSchema = external_exports.object({
+  type: external_exports.string(),
+  label: external_exports.string(),
+  count: external_exports.number().int().nonnegative(),
+  status: ClauseEvidenceStatusSchema
+});
+var ClauseEvidenceNodeSchema = external_exports.object({
+  clauseId: external_exports.string(),
+  clauseNumber: external_exports.string(),
+  clauseTitle: external_exports.string(),
+  status: ClauseEvidenceStatusSchema,
+  evidenceCount: external_exports.number().int().nonnegative(),
+  evidence: external_exports.array(ClauseEvidenceItemSchema)
+});
+var FrameworkEvidenceResponseSchema = external_exports.object({
+  frameworkId: RegulatoryFrameworkSchema,
+  frameworkName: external_exports.string(),
+  totalClauses: external_exports.number().int().nonnegative(),
+  coveredClauses: external_exports.number().int().nonnegative(),
+  partialClauses: external_exports.number().int().nonnegative(),
+  missingClauses: external_exports.number().int().nonnegative(),
+  clauses: external_exports.array(ClauseEvidenceNodeSchema)
 });
 var SCHEMA_MAP = {
   // Risk entries
@@ -22919,7 +25777,7 @@ var client = new PactoSignaApiClient({
   apiKey: PACTOSIGNA_API_KEY
 });
 var server = new Server(
-  { name: "pactosigna", version: "0.1.8" },
+  { name: "pactosigna", version: "0.1.9" },
   { capabilities: { tools: {} } }
 );
 server.setRequestHandler(ListToolsRequestSchema, async () => ({