@pactosigna/schemas 0.1.0 → 0.1.2

package/dist/chunk-A3X6VKYK.js

@@ -0,0 +1,141 @@
+// src/document-type-patterns.ts
+var FOLDER_RULES = {
+  // Product (ISO 13485 §7.3)
+  "docs/product": {
+    prefixes: ["PDP-", "IU-"],
+    type: ["product_development_plan", "intended_use"]
+  },
+  "docs/product/requirements": { prefixes: ["PRS-"], type: "requirement", category: "product" },
+  "docs/product/user-needs": { prefixes: ["UN-"], type: "user_need" },
+  // Software requirements (moved under software discipline)
+  "docs/software/requirements": { prefixes: ["SRS-"], type: "requirement", category: "software" },
+  // Design (IEC 62304 — under software discipline)
+  "docs/software/architecture": { prefixes: ["HLD-", "SAD-", "DEV-PLAN-"], type: "architecture" },
+  "docs/software/design": { prefixes: ["SDD-", "DDD-"], type: "detailed_design" },
+  // Test (protocols + reports)
+  "docs/test/protocols": { prefixes: ["TP-"], type: "test_protocol" },
+  "docs/test/reports": { prefixes: ["TR-"], type: "test_report" },
+  // Risk management — ISO 14971 (umbrella)
+  "docs/risk/plans": { prefixes: ["RMP-"], type: "risk_management_plan" },
+  "docs/risk/situations": { prefixes: ["HS-"], type: "hazardous_situation" },
+  "docs/risk/harms": { prefixes: ["HARM-"], type: "harm" },
+  "docs/risk/hazard-categories": { prefixes: ["HC-"], type: "hazard_category" },
+  // Software lifecycle — IEC 62304
+  "docs/software/plans": {
+    prefixes: ["DEV-PLAN-", "MAINT-PLAN-", "SDP-", "STP-"],
+    type: [
+      "software_development_plan",
+      "software_maintenance_plan",
+      "software_development_plan",
+      "software_test_plan"
+    ]
+  },
+  "docs/software/risks": {
+    prefixes: ["HAZ-SW-", "RISK-SW-"],
+    type: ["haz_soe_software", "software_risk"]
+  },
+  "docs/software/soup": { prefixes: ["SOUP-"], type: "soup_register" },
+  // Problem resolution — IEC 62304 §9
+  "docs/software/anomalies": { prefixes: ["ANOM-"], type: "anomaly" },
+  // Cybersecurity — IEC 81001-5-1
+  "docs/cybersecurity/plans": { prefixes: ["CSPLAN-"], type: "cybersecurity_plan" },
+  "docs/cybersecurity/risks": {
+    prefixes: ["HAZ-SEC-", "RISK-SEC-"],
+    type: ["haz_soe_security", "security_risk"]
+  },
+  "docs/cybersecurity/sbom": { prefixes: ["SBOM-"], type: "sbom" },
+  // Usability engineering — IEC 62366
+  "docs/usability": { prefixes: ["UEP-"], type: "usability_plan" },
+  "docs/usability/use-specifications": { prefixes: ["US-"], type: "use_specification" },
+  "docs/usability/task-analyses": { prefixes: ["TA-"], type: "task_analysis" },
+  "docs/usability/evaluations": {
+    prefixes: ["UE-", "SE-"],
+    type: ["usability_evaluation", "summative_evaluation"]
+  },
+  "docs/usability/risks": { prefixes: ["RISK-US-"], type: "usability_risk" },
+  // Clinical — MDR / FDA
+  "docs/clinical": {
+    prefixes: ["CEP-", "CER-"],
+    type: ["clinical_evaluation_plan", "clinical_evaluation_report"]
+  },
+  // Post-market surveillance — MDR Art. 83
+  "docs/post-market": { prefixes: ["PMS-"], type: "post_market_surveillance_plan" },
+  "docs/post-market/feedback": { prefixes: ["PMF-"], type: "post_market_feedback" },
+  // Change management — ISO 13485 §7.3.5
+  "docs/change/drm": { prefixes: ["DRM-"], type: "design_review" },
+  "docs/change/release-plans": { prefixes: ["RP-"], type: "release_plan" },
+  "docs/change/release-notes": { prefixes: ["RN-"], type: "release_notes" },
+  // Labeling — MDR Annex I
+  "docs/labeling": { prefixes: ["LBL-"], type: "labeling" },
+  // QMS documents
+  "docs/policies": { prefixes: ["POL-"], type: "policy" },
+  "docs/sops": { prefixes: ["SOP-"], type: "sop" },
+  "docs/work-instructions": { prefixes: ["WI-"], type: "work_instruction" },
+  // Internal audit management (ISO 13485 §8.2.2)
+  "docs/audits/schedules": { prefixes: ["AUD-SCH-"], type: "audit_schedule" },
+  "docs/audits/reports": { prefixes: ["AUD-RPT-"], type: "audit_report" },
+  // Management review (ISO 13485 §5.6)
+  "docs/management-reviews": { prefixes: ["MR-"], type: "management_review" },
+  // Supplier management (ISO 13485 §7.4)
+  "docs/suppliers": { prefixes: ["SUP-"], type: "supplier" }
+};
+var JSON_SBOM_FOLDERS = ["docs/cybersecurity/sbom"];
+var NON_REGULATED_FOLDERS = ["docs/compliance", "docs/user-guide", "docs/legal"];
+function normalizePath(path) {
+  return path.toLowerCase().replace(/\\/g, "/");
+}
+function extractFolder(filePath) {
+  const normalized = normalizePath(filePath);
+  const parts = normalized.split("/");
+  parts.pop();
+  return parts.join("/");
+}
+function findFolderRule(filePath) {
+  const folder = extractFolder(filePath);
+  if (FOLDER_RULES[folder]) {
+    return { rule: FOLDER_RULES[folder], folder };
+  }
+  const parts = folder.split("/");
+  while (parts.length > 0) {
+    const partial = parts.join("/");
+    if (FOLDER_RULES[partial]) {
+      return { rule: FOLDER_RULES[partial], folder: partial };
+    }
+    parts.pop();
+  }
+  return null;
+}
+function inferDocumentType(filePath, documentId) {
+  const match = findFolderRule(filePath);
+  if (!match) {
+    return null;
+  }
+  const { rule } = match;
+  if (typeof rule.type === "string") {
+    return {
+      docType: rule.type,
+      category: rule.category
+    };
+  }
+  const prefixIndex = rule.prefixes.findIndex(
+    (prefix) => documentId.toUpperCase().startsWith(prefix.toUpperCase())
+  );
+  if (prefixIndex === -1) {
+    return {
+      docType: rule.type[0],
+      category: rule.category
+    };
+  }
+  return {
+    docType: rule.type[prefixIndex],
+    category: rule.category
+  };
+}
+
+export {
+  FOLDER_RULES,
+  JSON_SBOM_FOLDERS,
+  NON_REGULATED_FOLDERS,
+  findFolderRule,
+  inferDocumentType
+};