@pactosigna/mcp-server 0.1.23 → 0.1.24

This diff represents the content of publicly available package versions that have been released to one of the supported registries. The information contained in this diff is provided for informational purposes only and reflects changes between package versions as they appear in their respective public registries.
Files changed (2) hide show
  1. package/dist/index.js +44 -100
  2. package/package.json +1 -1
package/dist/index.js CHANGED
@@ -21758,11 +21758,6 @@ var DEVICE_DOCUMENT_TYPES = [
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  // Product (ISO 13485 §7.3)
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  "product_development_plan",
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  "intended_use",
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- // Release management (IEC 62304 §5.7)
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- "release_plan",
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- // Change management (ISO 13485 §7.3.5)
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- "design_review",
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- "release_notes",
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  // Software test plan (IEC 62304 §5.7)
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  "software_test_plan"
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  ];
@@ -21813,11 +21808,6 @@ var DOCUMENT_TYPES = {
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  // Product (ISO 13485 §7.3)
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  product_development_plan: "Product Development Plan",
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  intended_use: "Intended Use",
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- // Release management (IEC 62304 §5.7)
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- release_plan: "Release Plan",
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- // Change management (ISO 13485 §7.3.5)
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- design_review: "Design Review",
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- release_notes: "Release Notes",
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  // Supplier management (ISO 13485 §7.4)
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  supplier: "Supplier",
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  // Internal audit management (ISO 13485 §8.2.2)
@@ -21844,9 +21834,6 @@ var REQUIRED_SECTIONS = {
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  user_need: ["User Story", "Validation Criteria"],
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  architecture: ["Purpose", "Architecture Overview", "Interfaces"],
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  detailed_design: ["Purpose", "Detailed Design", "Interfaces"],
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- release_plan: ["Scope", "Applicable Plans", "Release-Specific Criteria", "Known Anomalies"],
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- design_review: ["Review Scope", "Attendees", "Findings", "Actions", "Conclusion"],
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- release_notes: ["Changes", "Known Issues"],
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  audit_schedule: ["Scope", "Audit Criteria"],
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  audit_report: ["Scope", "Methodology", "Findings", "Conclusion"],
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  // Deprecated: management reviews are in-app entities, not git-native documents (#707)
@@ -22525,11 +22512,6 @@ var DocumentTypeSchema = external_exports.enum([
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  // Product (ISO 13485 §7.3)
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  "product_development_plan",
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  "intended_use",
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- // Release management (IEC 62304 §5.7)
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- "release_plan",
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- // Change management (ISO 13485 §7.3.5)
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- "design_review",
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- "release_notes",
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  // Supplier management (ISO 13485 §7.4)
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  "supplier",
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  // Internal audit management (ISO 13485 §8.2.2)
@@ -23224,63 +23206,9 @@ var DeviceDocumentTypeSchema = external_exports.enum([
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  // Product (ISO 13485 §7.3)
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  "product_development_plan",
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  "intended_use",
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- // Release management (IEC 62304 §5.7)
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- "release_plan",
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- // Change management (ISO 13485 §7.3.5)
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- "design_review",
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- "release_notes",
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  // Software test plan (IEC 62304 §5.7)
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  "software_test_plan"
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  ]);
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- var ReleasePlanFrontmatterSchema = external_exports.object({
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- id: external_exports.string().min(1),
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- title: external_exports.string().min(1),
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- type: external_exports.literal("release_plan").optional(),
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- status: external_exports.string().optional(),
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- author: external_exports.string().optional(),
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- reviewers: external_exports.array(external_exports.string()).optional(),
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- approvers: external_exports.array(external_exports.string()).optional(),
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- version: external_exports.string().optional(),
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- target_date: external_exports.string().optional(),
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- applicable_plans: external_exports.array(external_exports.string()).optional()
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- });
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- var SuspectedLinkDispositionSchema = external_exports.enum(["included_in_release", "not_impacted"]);
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- var SuspectedLinkNeighborSchema = external_exports.object({
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- document: external_exports.string().min(1),
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- direction: external_exports.enum(["upstream", "downstream"]),
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- disposition: SuspectedLinkDispositionSchema,
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- /** Required when disposition is 'not_impacted' */
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- rationale: external_exports.string().min(1).optional()
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- });
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- var SuspectedLinkGroupSchema = external_exports.object({
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- triggered_by: external_exports.string().min(1),
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- neighbors: external_exports.array(SuspectedLinkNeighborSchema).min(1)
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- });
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- var DesignReviewFrontmatterSchema = external_exports.object({
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- id: external_exports.string().min(1),
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- title: external_exports.string().min(1),
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- type: external_exports.literal("design_review").optional(),
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- status: external_exports.string().optional(),
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- author: external_exports.string().optional(),
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- reviewers: external_exports.array(external_exports.string()).optional(),
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- approvers: external_exports.array(external_exports.string()).optional(),
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- /** Optional link to a Release Plan document (e.g. "RP-001") */
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- release_plan: external_exports.string().optional(),
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- /** Acknowledged suspected links — one-up/one-down neighbor analysis */
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- suspected_links: external_exports.array(SuspectedLinkGroupSchema).optional()
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- });
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- var ReleaseNotesAudienceSchema = external_exports.enum(["customer", "technical"]);
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- var ReleaseNotesFrontmatterSchema = external_exports.object({
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- id: external_exports.string().min(1),
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- title: external_exports.string().min(1),
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- type: external_exports.literal("release_notes").optional(),
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- status: RiskDocumentStatusSchema,
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- author: external_exports.string().optional(),
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- reviewers: external_exports.array(external_exports.string()).optional(),
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- approvers: external_exports.array(external_exports.string()).optional(),
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- audience: ReleaseNotesAudienceSchema,
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- release_version: external_exports.string().min(1)
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- });
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  var RetentionPolicySchema = external_exports.object({
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  /** Default retention period in years for all record types */
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  defaultPeriodYears: external_exports.number().int().min(1).max(30).default(10),
@@ -23522,14 +23450,6 @@ var AuditActionSchema = external_exports.enum([
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  "dco.obligation_fulfilled",
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  "dco.approved",
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  "dco.effective",
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- // Design Reviews
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- "design_review.created",
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- "design_review.updated",
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- "design_review.deleted",
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- "design_review.submitted",
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- "design_review.signature_added",
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- "design_review.signed",
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- "design_review.cancelled",
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  // CAPAs
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  "capa.created",
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  "capa.updated",
@@ -23619,7 +23539,6 @@ var ResourceTypeSchema = external_exports.enum([
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  "qms",
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  "device",
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  "dco",
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- "design_review",
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  "signing_request",
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  "capa",
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  "complaint",
@@ -24314,6 +24233,38 @@ var RiskListResponseSchema = external_exports.object({
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  risks: external_exports.array(RiskListItemSchema),
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  total: external_exports.number()
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  });
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+ var KnownAnomalySeveritySchema = external_exports.enum(["cosmetic", "minor", "major"]);
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+ var KnownAnomalyEntrySchema = external_exports.object({
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+ title: external_exports.string().min(1).max(200),
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+ description: external_exports.string().min(1).max(2e3),
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+ severity: KnownAnomalySeveritySchema,
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+ acceptanceRationale: external_exports.string().min(1).max(2e3),
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+ createdBy: external_exports.string().min(1),
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+ createdAt: external_exports.string().datetime()
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+ });
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+ var ReviewFindingTypeSchema = external_exports.enum(["finding", "action", "observation"]);
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+ var ReviewFindingEntrySchema = external_exports.object({
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+ type: ReviewFindingTypeSchema,
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+ description: external_exports.string().min(1).max(2e3),
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+ assignee: external_exports.string().max(200).optional(),
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+ dueDate: external_exports.string().datetime().optional(),
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+ resolvedAt: external_exports.string().datetime().optional(),
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+ createdBy: external_exports.string().min(1),
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+ createdAt: external_exports.string().datetime()
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+ });
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+ var DispositionDirectionSchema = external_exports.enum(["upstream", "downstream"]);
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+ var DispositionOutcomeSchema = external_exports.enum(["included_in_release", "not_impacted"]);
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+ var SuspectedLinkDispositionEntrySchema = external_exports.object({
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+ triggeredByDocumentId: external_exports.string().min(1),
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+ neighborDocumentId: external_exports.string().min(1),
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+ direction: DispositionDirectionSchema,
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+ disposition: DispositionOutcomeSchema,
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+ rationale: external_exports.string().max(2e3).optional(),
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+ confirmedBy: external_exports.string().min(1),
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+ confirmedAt: external_exports.string().datetime()
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+ });
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+ var CustomerChangeSummarySchema = external_exports.string().max(5e3).optional();
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+ var CustomerKnownIssuesSchema = external_exports.string().max(5e3).optional();
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  var ReleaseTypeSchema = external_exports.enum(["qms", "device"]);
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  var ReleaseStatusSchema = external_exports.enum(["draft", "in_review", "approved", "published"]);
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  var SignatureTypeSchema = external_exports.enum([
@@ -24380,9 +24331,6 @@ var CreateReleaseRequestSchema = external_exports.object({
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  description: external_exports.string().max(2e3).optional(),
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  type: ReleaseTypeSchema,
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  deviceId: external_exports.string().optional(),
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- releasePlanDocumentId: external_exports.string().min(1).optional(),
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- designReviewId: external_exports.string().min(1).optional(),
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- releaseNotesDocumentId: external_exports.string().min(1).optional(),
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  deviationNotes: external_exports.string().max(5e3).optional(),
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  dhr: DHRMetadataSchema.optional(),
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  reason: external_exports.string().max(500).optional()
@@ -24391,13 +24339,15 @@ var UpdateReleaseRequestSchema = external_exports.object({
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  organizationId: external_exports.string().min(1),
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  name: external_exports.string().min(1).max(200).optional(),
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  description: external_exports.string().max(2e3).optional(),
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- releasePlanDocumentId: external_exports.string().min(1).nullable().optional(),
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- designReviewId: external_exports.string().min(1).nullable().optional(),
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- releaseNotesDocumentId: external_exports.string().min(1).nullable().optional(),
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  deviationNotes: external_exports.string().max(5e3).optional(),
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  dhr: DHRMetadataSchema.nullable().optional(),
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  deploymentReferences: external_exports.array(DeploymentReferenceSchema).optional(),
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  smokeTestEvidence: external_exports.array(DHRTestEvidenceEntrySchema).optional(),
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+ knownAnomalies: external_exports.array(KnownAnomalyEntrySchema).optional(),
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+ reviewFindings: external_exports.array(ReviewFindingEntrySchema).optional(),
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+ suspectedLinkDispositions: external_exports.array(SuspectedLinkDispositionEntrySchema).optional(),
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+ customerChangeSummary: CustomerChangeSummarySchema,
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+ customerKnownIssues: CustomerKnownIssuesSchema,
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  reason: external_exports.string().max(500).optional()
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  }).strict();
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  var AddSignatureRequestSchema = external_exports.object({
@@ -24620,9 +24570,6 @@ var ReleaseSummaryResponseSchema = external_exports.object({
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  obligationsDerivedAt: external_exports.string().optional(),
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  obligationsDerivationVersion: external_exports.number().optional(),
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  obligationsInputHash: external_exports.string().optional(),
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- releasePlanDocumentId: external_exports.string().optional(),
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- designReviewId: external_exports.string().optional(),
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- releaseNotesDocumentId: external_exports.string().optional(),
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  deviationNotes: external_exports.string().optional(),
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  dhr: DHRMetadataResponseSchema.optional(),
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  version: external_exports.string().optional()
@@ -24639,7 +24586,12 @@ var ReleaseDetailResponseSchema = ReleaseSummaryResponseSchema.extend({
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  deploymentReferences: external_exports.array(DeploymentReferenceResponseSchema).optional(),
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  smokeTestEvidence: external_exports.array(external_exports.object({ label: external_exports.string(), url: external_exports.string() })).optional(),
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  gateOverrides: external_exports.array(GateOverrideResponseSchema).default([]),
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- documentManifest: external_exports.array(ReleaseDocumentManifestEntrySchema).optional()
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+ documentManifest: external_exports.array(ReleaseDocumentManifestEntrySchema).optional(),
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+ knownAnomalies: external_exports.array(KnownAnomalyEntrySchema).optional(),
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+ reviewFindings: external_exports.array(ReviewFindingEntrySchema).optional(),
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+ suspectedLinkDispositions: external_exports.array(SuspectedLinkDispositionEntrySchema).optional(),
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+ customerChangeSummary: external_exports.string().optional(),
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+ customerKnownIssues: external_exports.string().optional()
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  });
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  var ListReleasesResponseSchema = external_exports.object({
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  releases: external_exports.array(ReleaseSummaryResponseSchema),
@@ -24779,10 +24731,6 @@ var SignatureCaptureContextSchema = external_exports.discriminatedUnion("type",
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  type: external_exports.literal("release"),
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  id: external_exports.string().min(1)
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  }),
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- external_exports.object({
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- type: external_exports.literal("design_review"),
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- id: external_exports.string().min(1)
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- }),
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  external_exports.object({
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  type: external_exports.literal("dco"),
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  id: external_exports.string().min(1)
@@ -25696,10 +25644,6 @@ var SCHEMA_MAP = {
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  // Test documents
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  test_protocol: TestProtocolFrontmatterSchema,
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  test_report: TestReportFrontmatterSchema,
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- // Change management (ISO 13485 §7.3.5)
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- release_plan: ReleasePlanFrontmatterSchema,
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- design_review: DesignReviewFrontmatterSchema,
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- release_notes: ReleaseNotesFrontmatterSchema,
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  // Internal audit management (ISO 13485 §8.2.2)
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  audit_schedule: AuditScheduleFrontmatterSchema,
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  audit_report: AuditReportFrontmatterSchema,
@@ -25953,7 +25897,7 @@ var client = new PactoSignaApiClient({
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  apiKey: PACTOSIGNA_API_KEY
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  });
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  var server = new Server(
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- { name: "pactosigna", version: "0.1.23" },
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+ { name: "pactosigna", version: "0.1.24" },
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  { capabilities: { tools: {} } }
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  );
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  server.setRequestHandler(ListToolsRequestSchema, async () => ({
package/package.json CHANGED
@@ -1,6 +1,6 @@
1
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  {
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  "name": "@pactosigna/mcp-server",
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- "version": "0.1.23",
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+ "version": "0.1.24",
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  "type": "module",
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  "description": "MCP server for PactoSigna QMS — connects Claude Desktop, Cursor, and other AI tools to your quality management system",
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  "bin": {