@pactosigna/mcp-server 0.1.22 → 0.1.24

package/dist/index.js

@@ -21712,6 +21712,7 @@ var QMS_DOCUMENT_TYPES = [
   "audit_schedule",
   "audit_report",
   // Management review (ISO 13485 §5.6)
+  // @deprecated — management reviews are in-app entities (qualityReviews collection), not git-native documents
   "management_review"
 ];
 var DEVICE_DOCUMENT_TYPES = [
@@ -21757,11 +21758,6 @@ var DEVICE_DOCUMENT_TYPES = [
   // 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"
 ];
@@ -21812,11 +21808,6 @@ var DOCUMENT_TYPES = {
   // 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)
@@ -21843,11 +21834,9 @@ var REQUIRED_SECTIONS = {
   user_need: ["User Story", "Validation Criteria"],
   architecture: ["Purpose", "Architecture Overview", "Interfaces"],
   detailed_design: ["Purpose", "Detailed Design", "Interfaces"],
-  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"],
+  // Deprecated: management reviews are in-app entities, not git-native documents (#707)
   management_review: ["Review Inputs", "Review Outputs", "Action Items", "Decisions"],
   hazard_category: ["Description", "Examples", "Applicable Standards"],
   // Risk document body sections use BODY_FORMAT heading_pattern (## HARM-XXX via HS-XXX),
@@ -22523,11 +22512,6 @@ var DocumentTypeSchema = external_exports.enum([
   // 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",
   // Supplier management (ISO 13485 §7.4)
   "supplier",
   // Internal audit management (ISO 13485 §8.2.2)
@@ -23222,63 +23206,9 @@ var DeviceDocumentTypeSchema = external_exports.enum([
   // 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 ReleasePlanFrontmatterSchema = external_exports.object({
-  id: external_exports.string().min(1),
-  title: external_exports.string().min(1),
-  type: external_exports.literal("release_plan").optional(),
-  status: external_exports.string().optional(),
-  author: external_exports.string().optional(),
-  reviewers: external_exports.array(external_exports.string()).optional(),
-  approvers: external_exports.array(external_exports.string()).optional(),
-  version: external_exports.string().optional(),
-  target_date: external_exports.string().optional(),
-  applicable_plans: external_exports.array(external_exports.string()).optional()
-});
-var SuspectedLinkDispositionSchema = external_exports.enum(["included_in_release", "not_impacted"]);
-var SuspectedLinkNeighborSchema = external_exports.object({
-  document: external_exports.string().min(1),
-  direction: external_exports.enum(["upstream", "downstream"]),
-  disposition: SuspectedLinkDispositionSchema,
-  /** Required when disposition is 'not_impacted' */
-  rationale: external_exports.string().min(1).optional()
-});
-var SuspectedLinkGroupSchema = external_exports.object({
-  triggered_by: external_exports.string().min(1),
-  neighbors: external_exports.array(SuspectedLinkNeighborSchema).min(1)
-});
-var DesignReviewFrontmatterSchema = external_exports.object({
-  id: external_exports.string().min(1),
-  title: external_exports.string().min(1),
-  type: external_exports.literal("design_review").optional(),
-  status: external_exports.string().optional(),
-  author: external_exports.string().optional(),
-  reviewers: external_exports.array(external_exports.string()).optional(),
-  approvers: external_exports.array(external_exports.string()).optional(),
-  /** Optional link to a Release Plan document (e.g. "RP-001") */
-  release_plan: external_exports.string().optional(),
-  /** Acknowledged suspected links — one-up/one-down neighbor analysis */
-  suspected_links: external_exports.array(SuspectedLinkGroupSchema).optional()
-});
-var ReleaseNotesAudienceSchema = external_exports.enum(["customer", "technical"]);
-var ReleaseNotesFrontmatterSchema = external_exports.object({
-  id: external_exports.string().min(1),
-  title: external_exports.string().min(1),
-  type: external_exports.literal("release_notes").optional(),
-  status: RiskDocumentStatusSchema,
-  author: external_exports.string().optional(),
-  reviewers: external_exports.array(external_exports.string()).optional(),
-  approvers: external_exports.array(external_exports.string()).optional(),
-  audience: ReleaseNotesAudienceSchema,
-  release_version: external_exports.string().min(1)
-});
 var RetentionPolicySchema = external_exports.object({
   /** Default retention period in years for all record types */
   defaultPeriodYears: external_exports.number().int().min(1).max(30).default(10),
@@ -23520,14 +23450,6 @@ var AuditActionSchema = external_exports.enum([
   "dco.obligation_fulfilled",
   "dco.approved",
   "dco.effective",
-  // Design Reviews
-  "design_review.created",
-  "design_review.updated",
-  "design_review.deleted",
-  "design_review.submitted",
-  "design_review.signature_added",
-  "design_review.signed",
-  "design_review.cancelled",
   // CAPAs
   "capa.created",
   "capa.updated",
@@ -23617,7 +23539,6 @@ var ResourceTypeSchema = external_exports.enum([
   "qms",
   "device",
   "dco",
-  "design_review",
   "signing_request",
   "capa",
   "complaint",
@@ -24312,6 +24233,38 @@ var RiskListResponseSchema = external_exports.object({
   risks: external_exports.array(RiskListItemSchema),
   total: external_exports.number()
 });
+var KnownAnomalySeveritySchema = external_exports.enum(["cosmetic", "minor", "major"]);
+var KnownAnomalyEntrySchema = external_exports.object({
+  title: external_exports.string().min(1).max(200),
+  description: external_exports.string().min(1).max(2e3),
+  severity: KnownAnomalySeveritySchema,
+  acceptanceRationale: external_exports.string().min(1).max(2e3),
+  createdBy: external_exports.string().min(1),
+  createdAt: external_exports.string().datetime()
+});
+var ReviewFindingTypeSchema = external_exports.enum(["finding", "action", "observation"]);
+var ReviewFindingEntrySchema = external_exports.object({
+  type: ReviewFindingTypeSchema,
+  description: external_exports.string().min(1).max(2e3),
+  assignee: external_exports.string().max(200).optional(),
+  dueDate: external_exports.string().datetime().optional(),
+  resolvedAt: external_exports.string().datetime().optional(),
+  createdBy: external_exports.string().min(1),
+  createdAt: external_exports.string().datetime()
+});
+var DispositionDirectionSchema = external_exports.enum(["upstream", "downstream"]);
+var DispositionOutcomeSchema = external_exports.enum(["included_in_release", "not_impacted"]);
+var SuspectedLinkDispositionEntrySchema = external_exports.object({
+  triggeredByDocumentId: external_exports.string().min(1),
+  neighborDocumentId: external_exports.string().min(1),
+  direction: DispositionDirectionSchema,
+  disposition: DispositionOutcomeSchema,
+  rationale: external_exports.string().max(2e3).optional(),
+  confirmedBy: external_exports.string().min(1),
+  confirmedAt: external_exports.string().datetime()
+});
+var CustomerChangeSummarySchema = external_exports.string().max(5e3).optional();
+var CustomerKnownIssuesSchema = external_exports.string().max(5e3).optional();
 var ReleaseTypeSchema = external_exports.enum(["qms", "device"]);
 var ReleaseStatusSchema = external_exports.enum(["draft", "in_review", "approved", "published"]);
 var SignatureTypeSchema = external_exports.enum([
@@ -24378,9 +24331,6 @@ var CreateReleaseRequestSchema = external_exports.object({
   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()
@@ -24389,13 +24339,15 @@ 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(),
+  knownAnomalies: external_exports.array(KnownAnomalyEntrySchema).optional(),
+  reviewFindings: external_exports.array(ReviewFindingEntrySchema).optional(),
+  suspectedLinkDispositions: external_exports.array(SuspectedLinkDispositionEntrySchema).optional(),
+  customerChangeSummary: CustomerChangeSummarySchema,
+  customerKnownIssues: CustomerKnownIssuesSchema,
   reason: external_exports.string().max(500).optional()
 }).strict();
 var AddSignatureRequestSchema = external_exports.object({
@@ -24618,9 +24570,6 @@ var ReleaseSummaryResponseSchema = external_exports.object({
   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()
@@ -24637,7 +24586,12 @@ var ReleaseDetailResponseSchema = ReleaseSummaryResponseSchema.extend({
   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()
+  documentManifest: external_exports.array(ReleaseDocumentManifestEntrySchema).optional(),
+  knownAnomalies: external_exports.array(KnownAnomalyEntrySchema).optional(),
+  reviewFindings: external_exports.array(ReviewFindingEntrySchema).optional(),
+  suspectedLinkDispositions: external_exports.array(SuspectedLinkDispositionEntrySchema).optional(),
+  customerChangeSummary: external_exports.string().optional(),
+  customerKnownIssues: external_exports.string().optional()
 });
 var ListReleasesResponseSchema = external_exports.object({
   releases: external_exports.array(ReleaseSummaryResponseSchema),
@@ -24777,10 +24731,6 @@ var SignatureCaptureContextSchema = external_exports.discriminatedUnion("type",
     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)
@@ -25694,14 +25644,10 @@ var SCHEMA_MAP = {
   // Test documents
   test_protocol: TestProtocolFrontmatterSchema,
   test_report: TestReportFrontmatterSchema,
-  // Change management (ISO 13485 §7.3.5)
-  release_plan: ReleasePlanFrontmatterSchema,
-  design_review: DesignReviewFrontmatterSchema,
-  release_notes: ReleaseNotesFrontmatterSchema,
   // Internal audit management (ISO 13485 §8.2.2)
   audit_schedule: AuditScheduleFrontmatterSchema,
   audit_report: AuditReportFrontmatterSchema,
-  // Management review (ISO 13485 §5.6)
+  // Management review (ISO 13485 §5.6) — deprecated: in-app entity, not git-native (#707)
   management_review: ManagementReviewFrontmatterSchema
 };
 function getSchemaForDocumentType(type) {
@@ -25951,7 +25897,7 @@ var client = new PactoSignaApiClient({
   apiKey: PACTOSIGNA_API_KEY
 });
 var server = new Server(
-  { name: "pactosigna", version: "0.1.22" },
+  { name: "pactosigna", version: "0.1.24" },
   { capabilities: { tools: {} } }
 );
 server.setRequestHandler(ListToolsRequestSchema, async () => ({

package/package.json

@@ -1,6 +1,6 @@
 {
   "name": "@pactosigna/mcp-server",
-  "version": "0.1.22",
+  "version": "0.1.24",
   "type": "module",
   "description": "MCP server for PactoSigna QMS — connects Claude Desktop, Cursor, and other AI tools to your quality management system",
   "bin": {