@pactosigna/schemas 0.1.6 → 0.1.7

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Files changed (6) hide show
  1. package/dist/cli.js +3596 -530
  2. package/dist/{document-type-patterns-JuAGFi_j.d.ts → document-type-patterns-B_ahiCEa.d.ts} +15 -4
  3. package/dist/document-type-patterns.d.ts +2 -1
  4. package/dist/index.d.ts +109 -113
  5. package/dist/index.js +3735 -669
  6. package/package.json +2 -2
package/dist/index.d.ts CHANGED
@@ -1,21 +1,17 @@
1
+ export { A as AcceptabilityStatusSchema, a as DocumentStatusSchema, D as DocumentTypeSchema, F as FOLDER_RULES, b as FolderRule, J as JSON_SBOM_FOLDERS, L as LinkTypeSchema, N as NON_REGULATED_FOLDERS, S as SafetyClassSchema, f as findFolderRule, i as inferDocumentType } from './document-type-patterns-B_ahiCEa.js';
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  import { z } from 'zod';
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- import { D as DocumentType, L as LinkType } from './document-type-patterns-JuAGFi_j.js';
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- export { F as FOLDER_RULES, a as FolderRule, J as JSON_SBOM_FOLDERS, N as NON_REGULATED_FOLDERS, f as findFolderRule, i as inferDocumentType } from './document-type-patterns-JuAGFi_j.js';
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  /**
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- * Common Zod enum schemas shared across multiple schema files.
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- *
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- * Extracted from index.ts to avoid circular dependencies when other
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- * schema files (e.g. frameworks.ts) need to reference these enums
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- * while also being re-exported from index.ts.
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+ * Common types and enums shared across contexts
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  */
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+ type DocumentType = 'user_need' | 'requirement' | 'architecture' | 'detailed_design' | 'test_protocol' | 'test_report' | 'sop' | 'work_instruction' | 'policy' | 'usability_risk' | 'software_risk' | 'security_risk' | 'haz_soe_software' | 'haz_soe_security' | 'hazardous_situation' | 'harm' | 'hazard_category' | 'usability_plan' | 'use_specification' | 'task_analysis' | 'usability_evaluation' | 'summative_evaluation' | 'risk_management_plan' | 'software_development_plan' | 'software_maintenance_plan' | 'soup_register' | 'anomaly' | 'cybersecurity_plan' | 'sbom' | 'clinical_evaluation_plan' | 'clinical_evaluation_report' | 'post_market_surveillance_plan' | 'post_market_feedback' | 'labeling' | 'product_development_plan' | 'intended_use' | 'release_plan' | 'design_review' | 'release_notes' | 'supplier' | 'audit_schedule' | 'audit_report' | 'management_review' | 'software_test_plan';
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+ type LinkType = 'derives_from' | 'implements' | 'verified_by' | 'mitigates' | 'parent_of' | 'related_to' | 'leads_to' | 'results_in' | 'analyzes';
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+
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+ /**
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+ * Regulatory frameworks supported by the system
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+ */
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  declare const RegulatoryFrameworkSchema: z.ZodEnum<["ISO_13485", "IEC_62304", "FDA_21_CFR_820", "QMSR", "EU_MDR", "ISO_14971", "AI_ACT"]>;
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- declare const SafetyClassSchema: z.ZodEnum<["A", "B", "C"]>;
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- declare const DocumentTypeSchema: z.ZodEnum<["user_need", "requirement", "architecture", "detailed_design", "test_protocol", "test_report", "sop", "work_instruction", "policy", "usability_risk", "software_risk", "security_risk", "haz_soe_software", "haz_soe_security", "hazardous_situation", "harm", "hazard_category", "usability_plan", "use_specification", "task_analysis", "usability_evaluation", "summative_evaluation", "risk_management_plan", "software_development_plan", "software_maintenance_plan", "soup_register", "anomaly", "cybersecurity_plan", "sbom", "clinical_evaluation_plan", "clinical_evaluation_report", "post_market_surveillance_plan", "post_market_feedback", "labeling", "product_development_plan", "intended_use", "release_plan", "design_review", "release_notes", "supplier", "audit_schedule", "audit_report", "management_review", "software_test_plan"]>;
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- declare const DocumentStatusSchema: z.ZodEnum<["draft", "in_review", "approved", "obsolete", "example"]>;
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- declare const LinkTypeSchema: z.ZodEnum<["derives_from", "implements", "verified_by", "mitigates", "parent_of", "related_to", "leads_to", "results_in", "analyzes"]>;
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- declare const AcceptabilityStatusSchema: z.ZodEnum<["acceptable", "review_required", "unacceptable"]>;
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  declare const RiskDocumentStatusSchema: z.ZodEnum<["draft", "in_review", "approved", "effective", "archived", "example"]>;
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  declare const MitigationTargetSchema: z.ZodEnum<["sequence_probability", "harm_probability", "severity"]>;
@@ -79,12 +75,12 @@ declare const RiskEntryFrontmatterSchema: z.ZodEffects<z.ZodObject<{
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  cvss_score: z.ZodOptional<z.ZodNumber>;
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  cvss_vector: z.ZodOptional<z.ZodString>;
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  }, "strip", z.ZodTypeAny, {
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- type: "software_risk" | "usability_risk" | "security_risk";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ hazardous_situation: string;
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+ analyzes: string;
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+ type: "usability_risk" | "software_risk" | "security_risk";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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- analyzes: string;
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- hazardous_situation: string;
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  harm_assessments: {
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  harm: string;
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  inherent_probability?: number | undefined;
@@ -101,12 +97,12 @@ declare const RiskEntryFrontmatterSchema: z.ZodEffects<z.ZodObject<{
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  cvss_score?: number | undefined;
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  cvss_vector?: string | undefined;
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  }, {
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- type: "software_risk" | "usability_risk" | "security_risk";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ hazardous_situation: string;
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+ analyzes: string;
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+ type: "usability_risk" | "software_risk" | "security_risk";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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- analyzes: string;
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- hazardous_situation: string;
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  harm_assessments: {
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  harm: string;
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  inherent_probability?: number | undefined;
@@ -123,12 +119,12 @@ declare const RiskEntryFrontmatterSchema: z.ZodEffects<z.ZodObject<{
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  cvss_score?: number | undefined;
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  cvss_vector?: string | undefined;
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  }>, {
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- type: "software_risk" | "usability_risk" | "security_risk";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ hazardous_situation: string;
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+ analyzes: string;
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+ type: "usability_risk" | "software_risk" | "security_risk";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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- analyzes: string;
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- hazardous_situation: string;
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  harm_assessments: {
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  harm: string;
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  inherent_probability?: number | undefined;
@@ -145,12 +141,12 @@ declare const RiskEntryFrontmatterSchema: z.ZodEffects<z.ZodObject<{
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  cvss_score?: number | undefined;
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  cvss_vector?: string | undefined;
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  }, {
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- type: "software_risk" | "usability_risk" | "security_risk";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ hazardous_situation: string;
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+ analyzes: string;
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+ type: "usability_risk" | "software_risk" | "security_risk";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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- analyzes: string;
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- hazardous_situation: string;
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  harm_assessments: {
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  harm: string;
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  inherent_probability?: number | undefined;
@@ -181,28 +177,28 @@ declare const HazardFrontmatterSchema: z.ZodObject<{
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  hazard_category: z.ZodOptional<z.ZodString>;
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  }, "strip", z.ZodTypeAny, {
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  type: "haz_soe_software" | "haz_soe_security";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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+ hazard_category?: string | undefined;
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  leads_to?: string[] | undefined;
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  failure_mode?: string | undefined;
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  cause?: string | undefined;
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  detection_method?: string | undefined;
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  threat_category?: string | undefined;
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  attack_vector?: string | undefined;
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- hazard_category?: string | undefined;
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  }, {
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  type: "haz_soe_software" | "haz_soe_security";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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+ hazard_category?: string | undefined;
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  leads_to?: string[] | undefined;
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  failure_mode?: string | undefined;
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  cause?: string | undefined;
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  detection_method?: string | undefined;
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  threat_category?: string | undefined;
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  attack_vector?: string | undefined;
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- hazard_category?: string | undefined;
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  }>;
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  declare const HazardCategoryFrontmatterSchema: z.ZodObject<{
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  type: z.ZodLiteral<"hazard_category">;
@@ -212,13 +208,13 @@ declare const HazardCategoryFrontmatterSchema: z.ZodObject<{
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  source: z.ZodOptional<z.ZodString>;
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  }, "strip", z.ZodTypeAny, {
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  type: "hazard_category";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  source?: string | undefined;
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  }, {
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  type: "hazard_category";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  source?: string | undefined;
@@ -231,13 +227,13 @@ declare const HazardousSituationFrontmatterSchema: z.ZodObject<{
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  results_in: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
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  }, "strip", z.ZodTypeAny, {
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  type: "hazardous_situation";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  results_in?: string[] | undefined;
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  }, {
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  type: "hazardous_situation";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  results_in?: string[] | undefined;
@@ -252,14 +248,14 @@ declare const HarmFrontmatterSchema: z.ZodObject<{
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  }, "strip", z.ZodTypeAny, {
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  severity: number;
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  type: "harm";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  category?: string | undefined;
259
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  }, {
260
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  severity: number;
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  type: "harm";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  category?: string | undefined;
@@ -363,7 +359,7 @@ declare const UsabilityPlanFrontmatterSchema: z.ZodObject<{
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  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
364
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  }, "strip", z.ZodTypeAny, {
365
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  type: "usability_plan";
366
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  author?: string | undefined;
@@ -371,7 +367,7 @@ declare const UsabilityPlanFrontmatterSchema: z.ZodObject<{
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  approvers?: string[] | undefined;
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  }, {
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  type: "usability_plan";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  author?: string | undefined;
@@ -389,7 +385,7 @@ declare const UseSpecificationFrontmatterSchema: z.ZodObject<{
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  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
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  }, "strip", z.ZodTypeAny, {
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  type: "use_specification";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  user_group: string;
@@ -398,7 +394,7 @@ declare const UseSpecificationFrontmatterSchema: z.ZodObject<{
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  approvers?: string[] | undefined;
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  }, {
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  type: "use_specification";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  user_group: string;
@@ -418,7 +414,7 @@ declare const TaskAnalysisFrontmatterSchema: z.ZodObject<{
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  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
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  }, "strip", z.ZodTypeAny, {
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  type: "task_analysis";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  user_group: string;
@@ -428,7 +424,7 @@ declare const TaskAnalysisFrontmatterSchema: z.ZodObject<{
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  approvers?: string[] | undefined;
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  }, {
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  type: "task_analysis";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  user_group: string;
@@ -448,7 +444,7 @@ declare const UsabilityEvaluationFrontmatterSchema: z.ZodObject<{
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  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
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  }, "strip", z.ZodTypeAny, {
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  type: "usability_evaluation";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  author?: string | undefined;
@@ -457,7 +453,7 @@ declare const UsabilityEvaluationFrontmatterSchema: z.ZodObject<{
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  result?: "pass" | "fail" | "pass_with_findings" | undefined;
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  }, {
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  type: "usability_evaluation";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  author?: string | undefined;
@@ -476,7 +472,7 @@ declare const SummativeEvaluationFrontmatterSchema: z.ZodObject<{
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  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
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  }, "strip", z.ZodTypeAny, {
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  type: "summative_evaluation";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  author?: string | undefined;
@@ -485,7 +481,7 @@ declare const SummativeEvaluationFrontmatterSchema: z.ZodObject<{
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  result?: "pass" | "fail" | "pass_with_findings" | undefined;
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  }, {
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  type: "summative_evaluation";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  author?: string | undefined;
@@ -517,7 +513,7 @@ declare const RiskManagementPlanFrontmatterSchema: z.ZodObject<{
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  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
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  }, "strip", z.ZodTypeAny, {
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  type: "risk_management_plan";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  author?: string | undefined;
@@ -525,7 +521,7 @@ declare const RiskManagementPlanFrontmatterSchema: z.ZodObject<{
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  approvers?: string[] | undefined;
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  }, {
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  type: "risk_management_plan";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
531
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  author?: string | undefined;
@@ -548,7 +544,7 @@ declare const SoftwareDevelopmentPlanFrontmatterSchema: z.ZodObject<{
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  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
549
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  }, "strip", z.ZodTypeAny, {
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  type: "software_development_plan";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  author?: string | undefined;
@@ -556,7 +552,7 @@ declare const SoftwareDevelopmentPlanFrontmatterSchema: z.ZodObject<{
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  approvers?: string[] | undefined;
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  }, {
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  type: "software_development_plan";
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- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  author?: string | undefined;
@@ -573,7 +569,7 @@ declare const SoftwareMaintenancePlanFrontmatterSchema: z.ZodObject<{
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  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
574
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  }, "strip", z.ZodTypeAny, {
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  type: "software_maintenance_plan";
576
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  author?: string | undefined;
@@ -581,7 +577,7 @@ declare const SoftwareMaintenancePlanFrontmatterSchema: z.ZodObject<{
581
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  approvers?: string[] | undefined;
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  }, {
583
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  type: "software_maintenance_plan";
584
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
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+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  author?: string | undefined;
@@ -598,7 +594,7 @@ declare const SoupRegisterFrontmatterSchema: z.ZodObject<{
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  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
599
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  }, "strip", z.ZodTypeAny, {
600
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  type: "soup_register";
601
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
597
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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  author?: string | undefined;
@@ -606,7 +602,7 @@ declare const SoupRegisterFrontmatterSchema: z.ZodObject<{
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  approvers?: string[] | undefined;
607
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  }, {
608
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  type: "soup_register";
609
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
605
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
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  id: string;
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  title: string;
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608
  author?: string | undefined;
@@ -623,7 +619,7 @@ declare const SoftwareTestPlanFrontmatterSchema: z.ZodObject<{
623
619
  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
624
620
  }, "strip", z.ZodTypeAny, {
625
621
  type: "software_test_plan";
626
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
622
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
627
623
  id: string;
628
624
  title: string;
629
625
  author?: string | undefined;
@@ -631,7 +627,7 @@ declare const SoftwareTestPlanFrontmatterSchema: z.ZodObject<{
631
627
  approvers?: string[] | undefined;
632
628
  }, {
633
629
  type: "software_test_plan";
634
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
630
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
635
631
  id: string;
636
632
  title: string;
637
633
  author?: string | undefined;
@@ -668,10 +664,10 @@ declare const AnomalyFrontmatterSchema: z.ZodObject<{
668
664
  }, "strip", z.ZodTypeAny, {
669
665
  severity: "critical" | "major" | "minor";
670
666
  type: "anomaly";
671
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
667
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
672
668
  id: string;
673
669
  title: string;
674
- category: "performance" | "bug" | "security_vulnerability" | "regression";
670
+ category: "bug" | "security_vulnerability" | "regression" | "performance";
675
671
  disposition: "open" | "investigating" | "resolved" | "deferred" | "will_not_fix";
676
672
  author?: string | undefined;
677
673
  reviewers?: string[] | undefined;
@@ -680,10 +676,10 @@ declare const AnomalyFrontmatterSchema: z.ZodObject<{
680
676
  }, {
681
677
  severity: "critical" | "major" | "minor";
682
678
  type: "anomaly";
683
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
679
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
684
680
  id: string;
685
681
  title: string;
686
- category: "performance" | "bug" | "security_vulnerability" | "regression";
682
+ category: "bug" | "security_vulnerability" | "regression" | "performance";
687
683
  disposition: "open" | "investigating" | "resolved" | "deferred" | "will_not_fix";
688
684
  author?: string | undefined;
689
685
  reviewers?: string[] | undefined;
@@ -709,7 +705,7 @@ declare const CybersecurityPlanFrontmatterSchema: z.ZodObject<{
709
705
  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
710
706
  }, "strip", z.ZodTypeAny, {
711
707
  type: "cybersecurity_plan";
712
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
708
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
713
709
  id: string;
714
710
  title: string;
715
711
  author?: string | undefined;
@@ -717,7 +713,7 @@ declare const CybersecurityPlanFrontmatterSchema: z.ZodObject<{
717
713
  approvers?: string[] | undefined;
718
714
  }, {
719
715
  type: "cybersecurity_plan";
720
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
716
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
721
717
  id: string;
722
718
  title: string;
723
719
  author?: string | undefined;
@@ -734,7 +730,7 @@ declare const SbomFrontmatterSchema: z.ZodObject<{
734
730
  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
735
731
  }, "strip", z.ZodTypeAny, {
736
732
  type: "sbom";
737
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
733
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
738
734
  id: string;
739
735
  title: string;
740
736
  author?: string | undefined;
@@ -742,7 +738,7 @@ declare const SbomFrontmatterSchema: z.ZodObject<{
742
738
  approvers?: string[] | undefined;
743
739
  }, {
744
740
  type: "sbom";
745
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
741
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
746
742
  id: string;
747
743
  title: string;
748
744
  author?: string | undefined;
@@ -766,7 +762,7 @@ declare const ClinicalEvaluationPlanFrontmatterSchema: z.ZodObject<{
766
762
  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
767
763
  }, "strip", z.ZodTypeAny, {
768
764
  type: "clinical_evaluation_plan";
769
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
765
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
770
766
  id: string;
771
767
  title: string;
772
768
  author?: string | undefined;
@@ -774,7 +770,7 @@ declare const ClinicalEvaluationPlanFrontmatterSchema: z.ZodObject<{
774
770
  approvers?: string[] | undefined;
775
771
  }, {
776
772
  type: "clinical_evaluation_plan";
777
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
773
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
778
774
  id: string;
779
775
  title: string;
780
776
  author?: string | undefined;
@@ -791,7 +787,7 @@ declare const ClinicalEvaluationReportFrontmatterSchema: z.ZodObject<{
791
787
  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
792
788
  }, "strip", z.ZodTypeAny, {
793
789
  type: "clinical_evaluation_report";
794
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
790
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
795
791
  id: string;
796
792
  title: string;
797
793
  author?: string | undefined;
@@ -799,7 +795,7 @@ declare const ClinicalEvaluationReportFrontmatterSchema: z.ZodObject<{
799
795
  approvers?: string[] | undefined;
800
796
  }, {
801
797
  type: "clinical_evaluation_report";
802
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
798
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
803
799
  id: string;
804
800
  title: string;
805
801
  author?: string | undefined;
@@ -823,7 +819,7 @@ declare const PostMarketSurveillancePlanFrontmatterSchema: z.ZodObject<{
823
819
  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
824
820
  }, "strip", z.ZodTypeAny, {
825
821
  type: "post_market_surveillance_plan";
826
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
822
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
827
823
  id: string;
828
824
  title: string;
829
825
  author?: string | undefined;
@@ -831,7 +827,7 @@ declare const PostMarketSurveillancePlanFrontmatterSchema: z.ZodObject<{
831
827
  approvers?: string[] | undefined;
832
828
  }, {
833
829
  type: "post_market_surveillance_plan";
834
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
830
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
835
831
  id: string;
836
832
  title: string;
837
833
  author?: string | undefined;
@@ -854,9 +850,9 @@ declare const PostMarketFeedbackFrontmatterSchema: z.ZodObject<{
854
850
  reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
855
851
  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
856
852
  }, "strip", z.ZodTypeAny, {
857
- severity: "low" | "medium" | "high" | "critical";
853
+ severity: "critical" | "low" | "medium" | "high";
858
854
  type: "post_market_feedback";
859
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
855
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
860
856
  id: string;
861
857
  title: string;
862
858
  category: "complaint" | "field_observation" | "clinical_followup" | "trend_report";
@@ -866,9 +862,9 @@ declare const PostMarketFeedbackFrontmatterSchema: z.ZodObject<{
866
862
  device?: string | undefined;
867
863
  reporting_period?: string | undefined;
868
864
  }, {
869
- severity: "low" | "medium" | "high" | "critical";
865
+ severity: "critical" | "low" | "medium" | "high";
870
866
  type: "post_market_feedback";
871
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
867
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
872
868
  id: string;
873
869
  title: string;
874
870
  category: "complaint" | "field_observation" | "clinical_followup" | "trend_report";
@@ -895,7 +891,7 @@ declare const LabelingFrontmatterSchema: z.ZodObject<{
895
891
  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
896
892
  }, "strip", z.ZodTypeAny, {
897
893
  type: "labeling";
898
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
894
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
899
895
  id: string;
900
896
  title: string;
901
897
  author?: string | undefined;
@@ -904,7 +900,7 @@ declare const LabelingFrontmatterSchema: z.ZodObject<{
904
900
  label_type?: "ifu" | "product_label" | "packaging_label" | undefined;
905
901
  }, {
906
902
  type: "labeling";
907
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
903
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
908
904
  id: string;
909
905
  title: string;
910
906
  author?: string | undefined;
@@ -928,7 +924,7 @@ declare const ProductDevelopmentPlanFrontmatterSchema: z.ZodObject<{
928
924
  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
929
925
  }, "strip", z.ZodTypeAny, {
930
926
  type: "product_development_plan";
931
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
927
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
932
928
  id: string;
933
929
  title: string;
934
930
  author?: string | undefined;
@@ -936,7 +932,7 @@ declare const ProductDevelopmentPlanFrontmatterSchema: z.ZodObject<{
936
932
  approvers?: string[] | undefined;
937
933
  }, {
938
934
  type: "product_development_plan";
939
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
935
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
940
936
  id: string;
941
937
  title: string;
942
938
  author?: string | undefined;
@@ -953,7 +949,7 @@ declare const IntendedUseFrontmatterSchema: z.ZodObject<{
953
949
  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
954
950
  }, "strip", z.ZodTypeAny, {
955
951
  type: "intended_use";
956
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
952
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
957
953
  id: string;
958
954
  title: string;
959
955
  author?: string | undefined;
@@ -961,7 +957,7 @@ declare const IntendedUseFrontmatterSchema: z.ZodObject<{
961
957
  approvers?: string[] | undefined;
962
958
  }, {
963
959
  type: "intended_use";
964
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
960
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
965
961
  id: string;
966
962
  title: string;
967
963
  author?: string | undefined;
@@ -1005,7 +1001,7 @@ declare const UserNeedFrontmatterSchema: z.ZodObject<{
1005
1001
  reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
1006
1002
  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
1007
1003
  }, "strip", z.ZodTypeAny, {
1008
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
1004
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
1009
1005
  id: string;
1010
1006
  title: string;
1011
1007
  type?: "user_need" | undefined;
@@ -1017,7 +1013,7 @@ declare const UserNeedFrontmatterSchema: z.ZodObject<{
1017
1013
  priority?: "must_have" | "should_have" | "nice_to_have" | undefined;
1018
1014
  derives?: string[] | undefined;
1019
1015
  }, {
1020
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
1016
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
1021
1017
  id: string;
1022
1018
  title: string;
1023
1019
  type?: "user_need" | undefined;
@@ -1082,25 +1078,25 @@ declare const RequirementFrontmatterSchema: z.ZodObject<{
1082
1078
  /** Downstream traceability — IDs of documents this requirement traces to (e.g., SRS for PRS) */
1083
1079
  traces_to: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
1084
1080
  }, "strip", z.ZodTypeAny, {
1085
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
1081
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
1086
1082
  id: string;
1087
1083
  title: string;
1088
1084
  author?: string | undefined;
1089
1085
  reviewers?: string[] | undefined;
1090
1086
  approvers?: string[] | undefined;
1091
- req_type?: "safety" | "performance" | "usability" | "regulatory" | "functional" | "interface" | "security" | undefined;
1087
+ req_type?: "performance" | "functional" | "interface" | "security" | "usability" | "safety" | "regulatory" | undefined;
1092
1088
  format?: "standard" | "user_story" | undefined;
1093
1089
  fulfillment_type?: "labeling" | "usability" | "software" | "clinical" | "regulatory_doc" | "process" | undefined;
1094
1090
  traces_from?: string[] | undefined;
1095
1091
  traces_to?: string[] | undefined;
1096
1092
  }, {
1097
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
1093
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
1098
1094
  id: string;
1099
1095
  title: string;
1100
1096
  author?: string | undefined;
1101
1097
  reviewers?: string[] | undefined;
1102
1098
  approvers?: string[] | undefined;
1103
- req_type?: "safety" | "performance" | "usability" | "regulatory" | "functional" | "interface" | "security" | undefined;
1099
+ req_type?: "performance" | "functional" | "interface" | "security" | "usability" | "safety" | "regulatory" | undefined;
1104
1100
  format?: "standard" | "user_story" | undefined;
1105
1101
  fulfillment_type?: "labeling" | "usability" | "software" | "clinical" | "regulatory_doc" | "process" | undefined;
1106
1102
  traces_from?: string[] | undefined;
@@ -1125,7 +1121,7 @@ declare const TestProtocolFrontmatterSchema: z.ZodObject<{
1125
1121
  approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
1126
1122
  }, "strip", z.ZodTypeAny, {
1127
1123
  type: "test_protocol";
1128
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
1124
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
1129
1125
  id: string;
1130
1126
  title: string;
1131
1127
  author?: string | undefined;
@@ -1133,7 +1129,7 @@ declare const TestProtocolFrontmatterSchema: z.ZodObject<{
1133
1129
  approvers?: string[] | undefined;
1134
1130
  }, {
1135
1131
  type: "test_protocol";
1136
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
1132
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
1137
1133
  id: string;
1138
1134
  title: string;
1139
1135
  author?: string | undefined;
@@ -1153,7 +1149,7 @@ declare const TestReportFrontmatterSchema: z.ZodObject<{
1153
1149
  test_phase: z.ZodOptional<z.ZodEnum<["verification", "production"]>>;
1154
1150
  }, "strip", z.ZodTypeAny, {
1155
1151
  type: "test_report";
1156
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
1152
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
1157
1153
  id: string;
1158
1154
  title: string;
1159
1155
  author?: string | undefined;
@@ -1163,7 +1159,7 @@ declare const TestReportFrontmatterSchema: z.ZodObject<{
1163
1159
  test_phase?: "verification" | "production" | undefined;
1164
1160
  }, {
1165
1161
  type: "test_report";
1166
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
1162
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
1167
1163
  id: string;
1168
1164
  title: string;
1169
1165
  author?: string | undefined;
@@ -1189,11 +1185,11 @@ declare const ReleaseReviewConfigSchema: z.ZodObject<{
1189
1185
  required_departments: z.ZodArray<z.ZodString, "many">;
1190
1186
  final_approver: z.ZodString;
1191
1187
  }, "strip", z.ZodTypeAny, {
1192
- final_approver: string;
1193
1188
  required_departments: string[];
1194
- }, {
1195
1189
  final_approver: string;
1190
+ }, {
1196
1191
  required_departments: string[];
1192
+ final_approver: string;
1197
1193
  }>;
1198
1194
  type ReleaseReviewConfig = z.infer<typeof ReleaseReviewConfigSchema>;
1199
1195
  declare const RepoConfigSchema: z.ZodObject<{
@@ -1232,11 +1228,11 @@ declare const RepoConfigSchema: z.ZodObject<{
1232
1228
  required_departments: z.ZodArray<z.ZodString, "many">;
1233
1229
  final_approver: z.ZodString;
1234
1230
  }, "strip", z.ZodTypeAny, {
1235
- final_approver: string;
1236
1231
  required_departments: string[];
1237
- }, {
1238
1232
  final_approver: string;
1233
+ }, {
1239
1234
  required_departments: string[];
1235
+ final_approver: string;
1240
1236
  }>>;
1241
1237
  }, "strip", z.ZodTypeAny, {
1242
1238
  device: {
@@ -1249,8 +1245,8 @@ declare const RepoConfigSchema: z.ZodObject<{
1249
1245
  udi_device_identifier?: string | undefined;
1250
1246
  };
1251
1247
  release_review?: {
1252
- final_approver: string;
1253
1248
  required_departments: string[];
1249
+ final_approver: string;
1254
1250
  } | undefined;
1255
1251
  }, {
1256
1252
  device: {
@@ -1263,8 +1259,8 @@ declare const RepoConfigSchema: z.ZodObject<{
1263
1259
  udi_device_identifier?: string | undefined;
1264
1260
  };
1265
1261
  release_review?: {
1266
- final_approver: string;
1267
1262
  required_departments: string[];
1263
+ final_approver: string;
1268
1264
  } | undefined;
1269
1265
  }>;
1270
1266
  type RepoConfig = z.infer<typeof RepoConfigSchema>;
@@ -1362,12 +1358,12 @@ declare const DesignReviewFrontmatterSchema: z.ZodObject<{
1362
1358
  }, "strip", z.ZodTypeAny, {
1363
1359
  id: string;
1364
1360
  title: string;
1361
+ release_plan?: string | undefined;
1365
1362
  type?: "design_review" | undefined;
1366
1363
  status?: string | undefined;
1367
1364
  author?: string | undefined;
1368
1365
  reviewers?: string[] | undefined;
1369
1366
  approvers?: string[] | undefined;
1370
- release_plan?: string | undefined;
1371
1367
  suspected_links?: {
1372
1368
  triggered_by: string;
1373
1369
  neighbors: {
@@ -1380,12 +1376,12 @@ declare const DesignReviewFrontmatterSchema: z.ZodObject<{
1380
1376
  }, {
1381
1377
  id: string;
1382
1378
  title: string;
1379
+ release_plan?: string | undefined;
1383
1380
  type?: "design_review" | undefined;
1384
1381
  status?: string | undefined;
1385
1382
  author?: string | undefined;
1386
1383
  reviewers?: string[] | undefined;
1387
1384
  approvers?: string[] | undefined;
1388
- release_plan?: string | undefined;
1389
1385
  suspected_links?: {
1390
1386
  triggered_by: string;
1391
1387
  neighbors: {
@@ -1410,7 +1406,7 @@ declare const ReleaseNotesFrontmatterSchema: z.ZodObject<{
1410
1406
  audience: z.ZodEnum<["customer", "technical"]>;
1411
1407
  release_version: z.ZodString;
1412
1408
  }, "strip", z.ZodTypeAny, {
1413
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
1409
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
1414
1410
  id: string;
1415
1411
  title: string;
1416
1412
  release_version: string;
@@ -1420,7 +1416,7 @@ declare const ReleaseNotesFrontmatterSchema: z.ZodObject<{
1420
1416
  reviewers?: string[] | undefined;
1421
1417
  approvers?: string[] | undefined;
1422
1418
  }, {
1423
- status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
1419
+ status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
1424
1420
  id: string;
1425
1421
  title: string;
1426
1422
  release_version: string;
@@ -1501,14 +1497,14 @@ declare const PlannedAuditEntrySchema: z.ZodObject<{
1501
1497
  status: z.ZodEnum<["planned", "in_progress", "completed", "cancelled"]>;
1502
1498
  }, "strip", z.ZodTypeAny, {
1503
1499
  auditor: string;
1504
- status: "in_progress" | "completed" | "cancelled" | "planned";
1500
+ status: "in_progress" | "completed" | "planned" | "cancelled";
1505
1501
  audit_id: string;
1506
1502
  process_area: string;
1507
1503
  planned_date: string;
1508
1504
  clause?: string | undefined;
1509
1505
  }, {
1510
1506
  auditor: string;
1511
- status: "in_progress" | "completed" | "cancelled" | "planned";
1507
+ status: "in_progress" | "completed" | "planned" | "cancelled";
1512
1508
  audit_id: string;
1513
1509
  process_area: string;
1514
1510
  planned_date: string;
@@ -1533,14 +1529,14 @@ declare const AuditScheduleFrontmatterSchema: z.ZodObject<{
1533
1529
  status: z.ZodEnum<["planned", "in_progress", "completed", "cancelled"]>;
1534
1530
  }, "strip", z.ZodTypeAny, {
1535
1531
  auditor: string;
1536
- status: "in_progress" | "completed" | "cancelled" | "planned";
1532
+ status: "in_progress" | "completed" | "planned" | "cancelled";
1537
1533
  audit_id: string;
1538
1534
  process_area: string;
1539
1535
  planned_date: string;
1540
1536
  clause?: string | undefined;
1541
1537
  }, {
1542
1538
  auditor: string;
1543
- status: "in_progress" | "completed" | "cancelled" | "planned";
1539
+ status: "in_progress" | "completed" | "planned" | "cancelled";
1544
1540
  audit_id: string;
1545
1541
  process_area: string;
1546
1542
  planned_date: string;
@@ -1552,7 +1548,7 @@ declare const AuditScheduleFrontmatterSchema: z.ZodObject<{
1552
1548
  cycle_year: number;
1553
1549
  audits: {
1554
1550
  auditor: string;
1555
- status: "in_progress" | "completed" | "cancelled" | "planned";
1551
+ status: "in_progress" | "completed" | "planned" | "cancelled";
1556
1552
  audit_id: string;
1557
1553
  process_area: string;
1558
1554
  planned_date: string;
@@ -1569,7 +1565,7 @@ declare const AuditScheduleFrontmatterSchema: z.ZodObject<{
1569
1565
  cycle_year: number;
1570
1566
  audits: {
1571
1567
  auditor: string;
1572
- status: "in_progress" | "completed" | "cancelled" | "planned";
1568
+ status: "in_progress" | "completed" | "planned" | "cancelled";
1573
1569
  audit_id: string;
1574
1570
  process_area: string;
1575
1571
  planned_date: string;
@@ -1700,11 +1696,11 @@ declare const ManagementReviewFrontmatterSchema: z.ZodObject<{
1700
1696
  from: z.ZodString;
1701
1697
  to: z.ZodString;
1702
1698
  }, "strip", z.ZodTypeAny, {
1703
- to: string;
1704
1699
  from: string;
1705
- }, {
1706
1700
  to: string;
1701
+ }, {
1707
1702
  from: string;
1703
+ to: string;
1708
1704
  }>;
1709
1705
  attendees: z.ZodArray<z.ZodObject<{
1710
1706
  name: z.ZodString;
@@ -1723,8 +1719,8 @@ declare const ManagementReviewFrontmatterSchema: z.ZodObject<{
1723
1719
  title: string;
1724
1720
  review_date: string;
1725
1721
  review_period: {
1726
- to: string;
1727
1722
  from: string;
1723
+ to: string;
1728
1724
  };
1729
1725
  attendees: {
1730
1726
  name: string;
@@ -1740,8 +1736,8 @@ declare const ManagementReviewFrontmatterSchema: z.ZodObject<{
1740
1736
  title: string;
1741
1737
  review_date: string;
1742
1738
  review_period: {
1743
- to: string;
1744
1739
  from: string;
1740
+ to: string;
1745
1741
  };
1746
1742
  attendees: {
1747
1743
  name: string;
@@ -1890,4 +1886,4 @@ declare function validateDirectory(dirPath: string, options?: {
1890
1886
  exclude?: string[];
1891
1887
  }): DirectoryValidationResult;
1892
1888
 
1893
- export { AcceptabilityStatusSchema, type AnomalyCategory, AnomalyCategorySchema, type AnomalyDisposition, AnomalyDispositionSchema, type AnomalyFrontmatter, AnomalyFrontmatterSchema, type AnomalySeverity, AnomalySeveritySchema, type AuditFinding, type AuditFindingClassification, AuditFindingClassificationSchema, AuditFindingSchema, type AuditReportFrontmatter, AuditReportFrontmatterSchema, type AuditScheduleFrontmatter, AuditScheduleFrontmatterSchema, type AuditStatus, AuditStatusSchema, CHANGE_DOCUMENT_TYPES, type ChangeDocumentType, type ClinicalEvaluationPlanFrontmatter, ClinicalEvaluationPlanFrontmatterSchema, type ClinicalEvaluationReportFrontmatter, ClinicalEvaluationReportFrontmatterSchema, type CybersecurityPlanFrontmatter, CybersecurityPlanFrontmatterSchema, DEVICE_DOCUMENT_TYPES, DOCUMENT_TYPES, type DesignReviewFrontmatter, DesignReviewFrontmatterSchema, type DeviceDocumentType, type DirectoryValidationResult, DocumentStatusSchema, DocumentTypeSchema, type HarmFrontmatter, HarmFrontmatterSchema, type HazardCategoryFrontmatter, HazardCategoryFrontmatterSchema, type HazardFrontmatter, HazardFrontmatterSchema, type HazardousSituationFrontmatter, HazardousSituationFrontmatterSchema, type IntendedUseFrontmatter, IntendedUseFrontmatterSchema, LINK_TYPES, type LabelingFrontmatter, LabelingFrontmatterSchema, LinkTypeSchema, type ManagementReviewAttendee, ManagementReviewAttendeeSchema, type ManagementReviewFrontmatter, ManagementReviewFrontmatterSchema, type Mitigation, MitigationSchema, MitigationTargetSchema, type PlannedAuditEntry, PlannedAuditEntrySchema, PostMarketFeedbackCategorySchema, type PostMarketFeedbackFrontmatter, PostMarketFeedbackFrontmatterSchema, PostMarketFeedbackSeveritySchema, type PostMarketSurveillancePlanFrontmatter, PostMarketSurveillancePlanFrontmatterSchema, type ProductDevelopmentPlanFrontmatter, ProductDevelopmentPlanFrontmatterSchema, QMS_DOCUMENT_TYPES, type QmsDocumentType, REQUIRED_SECTIONS, RegulatoryFrameworkSchema, type ReleaseNotesAudience, ReleaseNotesAudienceSchema, type ReleaseNotesFrontmatter, ReleaseNotesFrontmatterSchema, type ReleasePlanFrontmatter, ReleasePlanFrontmatterSchema, type ReleaseReviewConfig, ReleaseReviewConfigSchema, type RepoConfig, RepoConfigSchema, type RequirementFormat, RequirementFormatSchema, type RequirementFrontmatter, RequirementFrontmatterSchema, type RequirementFulfillmentType, RequirementFulfillmentTypeSchema, type RequirementType, RequirementTypeSchema, type RetentionPolicy, RetentionPolicySchema, type RiskDocumentStatus, RiskDocumentStatusSchema, type RiskEntryFrontmatter, RiskEntryFrontmatterSchema, RiskGapCodeSchema, RiskGapSeveritySchema, type RiskManagementPlanFrontmatter, RiskManagementPlanFrontmatterSchema, type RiskMatrixConfig, RiskMatrixConfigSchema, SCHEMA_MAP, SafetyClassSchema, type SbomFrontmatter, SbomFrontmatterSchema, type SoftwareDevelopmentPlanFrontmatter, SoftwareDevelopmentPlanFrontmatterSchema, type SoftwareMaintenancePlanFrontmatter, SoftwareMaintenancePlanFrontmatterSchema, type SoftwareTestPlanFrontmatter, SoftwareTestPlanFrontmatterSchema, type SoupRegisterFrontmatter, SoupRegisterFrontmatterSchema, type StructureError, type StructureWarning, type SummativeEvaluationFrontmatter, SummativeEvaluationFrontmatterSchema, type TaskAnalysisFrontmatter, TaskAnalysisFrontmatterSchema, type TestPhase, TestPhaseSchema, type TestProtocolFrontmatter, TestProtocolFrontmatterSchema, type TestReportFrontmatter, TestReportFrontmatterSchema, type UsabilityEvaluationFrontmatter, UsabilityEvaluationFrontmatterSchema, type UsabilityPlanFrontmatter, UsabilityPlanFrontmatterSchema, type UseSpecificationFrontmatter, UseSpecificationFrontmatterSchema, type UserNeedFrontmatter, UserNeedFrontmatterSchema, type UserNeedPriority, UserNeedPrioritySchema, type ValidationResult, getEffectiveRetentionYears, getSchemaForDocumentType, isChangeDocumentType, isDeviceDocumentType, isQmsDocumentType, isWithinRetentionPeriod, validateDirectory, validateDocument };
1889
+ export { type AnomalyCategory, AnomalyCategorySchema, type AnomalyDisposition, AnomalyDispositionSchema, type AnomalyFrontmatter, AnomalyFrontmatterSchema, type AnomalySeverity, AnomalySeveritySchema, type AuditFinding, type AuditFindingClassification, AuditFindingClassificationSchema, AuditFindingSchema, type AuditReportFrontmatter, AuditReportFrontmatterSchema, type AuditScheduleFrontmatter, AuditScheduleFrontmatterSchema, type AuditStatus, AuditStatusSchema, CHANGE_DOCUMENT_TYPES, type ChangeDocumentType, type ClinicalEvaluationPlanFrontmatter, ClinicalEvaluationPlanFrontmatterSchema, type ClinicalEvaluationReportFrontmatter, ClinicalEvaluationReportFrontmatterSchema, type CybersecurityPlanFrontmatter, CybersecurityPlanFrontmatterSchema, DEVICE_DOCUMENT_TYPES, DOCUMENT_TYPES, type DesignReviewFrontmatter, DesignReviewFrontmatterSchema, type DeviceDocumentType, type DirectoryValidationResult, type HarmFrontmatter, HarmFrontmatterSchema, type HazardCategoryFrontmatter, HazardCategoryFrontmatterSchema, type HazardFrontmatter, HazardFrontmatterSchema, type HazardousSituationFrontmatter, HazardousSituationFrontmatterSchema, type IntendedUseFrontmatter, IntendedUseFrontmatterSchema, LINK_TYPES, type LabelingFrontmatter, LabelingFrontmatterSchema, type ManagementReviewAttendee, ManagementReviewAttendeeSchema, type ManagementReviewFrontmatter, ManagementReviewFrontmatterSchema, type Mitigation, MitigationSchema, MitigationTargetSchema, type PlannedAuditEntry, PlannedAuditEntrySchema, PostMarketFeedbackCategorySchema, type PostMarketFeedbackFrontmatter, PostMarketFeedbackFrontmatterSchema, PostMarketFeedbackSeveritySchema, type PostMarketSurveillancePlanFrontmatter, PostMarketSurveillancePlanFrontmatterSchema, type ProductDevelopmentPlanFrontmatter, ProductDevelopmentPlanFrontmatterSchema, QMS_DOCUMENT_TYPES, type QmsDocumentType, REQUIRED_SECTIONS, RegulatoryFrameworkSchema, type ReleaseNotesAudience, ReleaseNotesAudienceSchema, type ReleaseNotesFrontmatter, ReleaseNotesFrontmatterSchema, type ReleasePlanFrontmatter, ReleasePlanFrontmatterSchema, type ReleaseReviewConfig, ReleaseReviewConfigSchema, type RepoConfig, RepoConfigSchema, type RequirementFormat, RequirementFormatSchema, type RequirementFrontmatter, RequirementFrontmatterSchema, type RequirementFulfillmentType, RequirementFulfillmentTypeSchema, type RequirementType, RequirementTypeSchema, type RetentionPolicy, RetentionPolicySchema, type RiskDocumentStatus, RiskDocumentStatusSchema, type RiskEntryFrontmatter, RiskEntryFrontmatterSchema, RiskGapCodeSchema, RiskGapSeveritySchema, type RiskManagementPlanFrontmatter, RiskManagementPlanFrontmatterSchema, type RiskMatrixConfig, RiskMatrixConfigSchema, SCHEMA_MAP, type SbomFrontmatter, SbomFrontmatterSchema, type SoftwareDevelopmentPlanFrontmatter, SoftwareDevelopmentPlanFrontmatterSchema, type SoftwareMaintenancePlanFrontmatter, SoftwareMaintenancePlanFrontmatterSchema, type SoftwareTestPlanFrontmatter, SoftwareTestPlanFrontmatterSchema, type SoupRegisterFrontmatter, SoupRegisterFrontmatterSchema, type StructureError, type StructureWarning, type SummativeEvaluationFrontmatter, SummativeEvaluationFrontmatterSchema, type TaskAnalysisFrontmatter, TaskAnalysisFrontmatterSchema, type TestPhase, TestPhaseSchema, type TestProtocolFrontmatter, TestProtocolFrontmatterSchema, type TestReportFrontmatter, TestReportFrontmatterSchema, type UsabilityEvaluationFrontmatter, UsabilityEvaluationFrontmatterSchema, type UsabilityPlanFrontmatter, UsabilityPlanFrontmatterSchema, type UseSpecificationFrontmatter, UseSpecificationFrontmatterSchema, type UserNeedFrontmatter, UserNeedFrontmatterSchema, type UserNeedPriority, UserNeedPrioritySchema, type ValidationResult, getEffectiveRetentionYears, getSchemaForDocumentType, isChangeDocumentType, isDeviceDocumentType, isQmsDocumentType, isWithinRetentionPeriod, validateDirectory, validateDocument };