@pactosigna/mcp-server 0.1.11 → 0.1.13

package/dist/index.js

@@ -21840,8 +21840,9 @@ var LINK_TYPES = {
   analyzes: "Analyzes"
 };
 var REQUIRED_SECTIONS = {
-  user_need: ["Purpose", "Stakeholder", "User Needs"],
-  architecture: ["Purpose"],
+  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"],
@@ -21849,9 +21850,8 @@ var REQUIRED_SECTIONS = {
   audit_report: ["Scope", "Methodology", "Findings", "Conclusion"],
   management_review: ["Review Inputs", "Review Outputs", "Action Items", "Decisions"],
   hazard_category: ["Description", "Examples", "Applicable Standards"],
-  software_risk: ["Harm Assessment"],
-  security_risk: ["Harm Assessment"],
-  usability_risk: ["Harm Assessment"],
+  // Risk document body sections use BODY_FORMAT heading_pattern (## HARM-XXX via HS-XXX),
+  // not a literal "Harm Assessment" heading. Validation is via BODY_FORMAT, not here.
   haz_soe_software: ["Intended Function", "Failure Cause", "Failure Mode", "Failure Effect"],
   haz_soe_security: [
     "STRIDE Category & Threat",
@@ -22826,28 +22826,38 @@ var SegregationSchema = external_exports.object({
 var ArchitectureFrontmatterSchema = external_exports.object({
   id: external_exports.string().min(1),
   title: external_exports.string().min(1),
+  /** Required — cannot be inferred from folder alone since architecture/ and design/ share parent */
   type: external_exports.literal("architecture"),
   status: RiskDocumentStatusSchema,
-  software_item_type: SoftwareItemTypeSchema.optional(),
+  /** IEC 62304 §5.3 — C4/IEC mapping: system, subsystem, component, unit (required) */
+  software_item_type: SoftwareItemTypeSchema,
+  /** Parent HLD doc ID (optional for system-level, recommended for subsystem/component) */
   parent_item: external_exports.string().optional(),
-  safety_class: external_exports.enum(["A", "B", "C"]).optional(),
+  safety_class: SafetyClassSchema.optional(),
   segregation: SegregationSchema.optional(),
-  author: external_exports.string().optional(),
+  /** Document author — required for all regulated document types */
+  author: external_exports.string().min(1),
   reviewers: external_exports.array(external_exports.string()).optional(),
-  approvers: external_exports.array(external_exports.string()).optional()
+  /** Approver list — required for all regulated document types */
+  approvers: external_exports.array(external_exports.string()).min(1)
 });
 var DetailedDesignFrontmatterSchema = external_exports.object({
   id: external_exports.string().min(1),
   title: external_exports.string().min(1),
+  /** Required — cannot be inferred from folder alone since architecture/ and design/ share parent */
   type: external_exports.literal("detailed_design"),
   status: RiskDocumentStatusSchema,
-  software_item_type: SoftwareItemTypeSchema.optional(),
-  parent_item: external_exports.string().optional(),
-  safety_class: external_exports.enum(["A", "B", "C"]).optional(),
+  /** IEC 62304 §5.4 — typically component or unit (required) */
+  software_item_type: SoftwareItemTypeSchema,
+  /** Parent HLD doc ID — required for SDD (must reference parent architecture) */
+  parent_item: external_exports.string().min(1),
+  safety_class: SafetyClassSchema.optional(),
   segregation: SegregationSchema.optional(),
-  author: external_exports.string().optional(),
+  /** Document author — required for all regulated document types */
+  author: external_exports.string().min(1),
   reviewers: external_exports.array(external_exports.string()).optional(),
-  approvers: external_exports.array(external_exports.string()).optional()
+  /** Approver list — required for all regulated document types */
+  approvers: external_exports.array(external_exports.string()).min(1)
 });
 var AnomalyCategorySchema = external_exports.enum([
   "bug",
@@ -22976,17 +22986,21 @@ var UserNeedFrontmatterSchema = external_exports.object({
   status: RiskDocumentStatusSchema,
   /** Validated if present — ensures frontmatter doesn't misidentify the document type */
   type: external_exports.literal("user_need").optional(),
-  /** The user role or stakeholder (e.g., "Quality Manager", "Developer") */
-  stakeholder: external_exports.string().optional(),
+  /** The user role or stakeholder (e.g., "Quality Manager", "Developer") — required per ISO 13485 §7.3.2 */
+  stakeholder: external_exports.string().min(1),
   /** MoSCoW priority classification */
   priority: UserNeedPrioritySchema.optional(),
   /** Where this need originated (e.g., "ISO 13485 §7.3", "user interview") */
   source: external_exports.string().optional(),
   /** IDs of product requirements derived from this need */
   derives: external_exports.array(external_exports.string()).optional(),
-  author: external_exports.string().optional(),
+  /** Document author — required for all regulated document types */
+  author: external_exports.string().min(1),
   reviewers: external_exports.array(external_exports.string()).optional(),
-  approvers: external_exports.array(external_exports.string()).optional()
+  /** Approver list — required for all regulated document types */
+  approvers: external_exports.array(external_exports.string()).min(1),
+  /** Optional reference to a Use Specification persona (US-xxx) per IEC 62366 */
+  use_specification: external_exports.string().optional()
 });
 var RequirementTypeSchema = external_exports.enum([
   "functional",
@@ -23024,6 +23038,46 @@ var RequirementFrontmatterSchema = external_exports.object({
   /** Downstream traceability — IDs of documents this requirement traces to (e.g., SRS for PRS) */
   traces_to: external_exports.array(external_exports.string()).optional()
 });
+var ProductRequirementFrontmatterSchema = external_exports.object({
+  id: external_exports.string().min(1),
+  title: external_exports.string().min(1),
+  status: RiskDocumentStatusSchema,
+  /** IEC 62304 §5.2.2 — requirement classification (optional for PRS) */
+  req_type: RequirementTypeSchema.optional(),
+  /** Authoring convention — controls which required sections are checked */
+  format: RequirementFormatSchema.optional(),
+  /** ISO 13485 §7.3.3 — how this PRS design input is fulfilled (defaults to 'software') */
+  fulfillment_type: RequirementFulfillmentTypeSchema.optional(),
+  /** Document author — required for all regulated document types */
+  author: external_exports.string().min(1),
+  reviewers: external_exports.array(external_exports.string()).optional(),
+  /** Approver list — required for all regulated document types */
+  approvers: external_exports.array(external_exports.string()).min(1),
+  /** Upstream traceability — IDs of User Need documents this PRS traces from (required) */
+  traces_from: external_exports.array(external_exports.string()).min(1),
+  /** Downstream traceability — IDs of SRS documents this PRS traces to */
+  traces_to: external_exports.array(external_exports.string()).optional()
+});
+var SoftwareRequirementFrontmatterSchema = external_exports.object({
+  id: external_exports.string().min(1),
+  title: external_exports.string().min(1),
+  status: RiskDocumentStatusSchema,
+  /** IEC 62304 §5.2.2 — requirement classification (recommended for SRS) */
+  req_type: RequirementTypeSchema.optional(),
+  /** Authoring convention — controls which required sections are checked */
+  format: RequirementFormatSchema.optional(),
+  /** Document author — required for all regulated document types */
+  author: external_exports.string().min(1),
+  reviewers: external_exports.array(external_exports.string()).optional(),
+  /** Approver list — required for all regulated document types */
+  approvers: external_exports.array(external_exports.string()).min(1),
+  /** Upstream traceability — IDs of PRS documents this SRS traces from (required) */
+  traces_from: external_exports.array(external_exports.string()).min(1),
+  /** Downstream traceability — IDs of documents this SRS traces to */
+  traces_to: external_exports.array(external_exports.string()).optional(),
+  /** HLD/SDD document ID that implements this requirement */
+  implemented_in: external_exports.string().optional()
+});
 var TestProtocolFrontmatterSchema = external_exports.object({
   type: external_exports.literal("test_protocol"),
   id: external_exports.string().min(1),
@@ -23294,7 +23348,8 @@ var EvidenceRuleConditionsSeedSchema = external_exports.object({
   documentType: DocumentTypeSchema.optional(),
   linkType: LinkTypeSchema.optional(),
   status: external_exports.string().optional(),
-  minCount: external_exports.number().int().positive().optional()
+  minCount: external_exports.number().int().positive().optional(),
+  safetyClass: SafetyClassSchema.optional()
 });
 var EvidenceRuleSeedSchema = external_exports.object({
   clauseId: external_exports.string().min(1),
@@ -25572,6 +25627,9 @@ var SCHEMA_MAP = {
   // Product (ISO 13485 §7.3)
   product_development_plan: ProductDevelopmentPlanFrontmatterSchema,
   intended_use: IntendedUseFrontmatterSchema,
+  // Architecture (IEC 62304 §5.3)
+  architecture: ArchitectureFrontmatterSchema,
+  detailed_design: DetailedDesignFrontmatterSchema,
   // User needs (ISO 13485 §7.3.2)
   user_need: UserNeedFrontmatterSchema,
   // Requirements (IEC 62304 §5.2.2, ISO 13485 §7.3.3)
@@ -25836,7 +25894,7 @@ var client = new PactoSignaApiClient({
   apiKey: PACTOSIGNA_API_KEY
 });
 var server = new Server(
-  { name: "pactosigna", version: "0.1.11" },
+  { name: "pactosigna", version: "0.1.13" },
   { capabilities: { tools: {} } }
 );
 server.setRequestHandler(ListToolsRequestSchema, async () => ({

package/package.json

@@ -1,6 +1,6 @@
 {
   "name": "@pactosigna/mcp-server",
-  "version": "0.1.11",
+  "version": "0.1.13",
   "type": "module",
   "description": "MCP server for PactoSigna QMS — connects Claude Desktop, Cursor, and other AI tools to your quality management system",
   "bin": {