@pactosigna/schemas 0.1.0 → 0.1.2
This diff represents the content of publicly available package versions that have been released to one of the supported registries. The information contained in this diff is provided for informational purposes only and reflects changes between package versions as they appear in their respective public registries.
- package/dist/chunk-A3X6VKYK.js +141 -0
- package/dist/cli.js +1545 -0
- package/dist/document-type-patterns-JuAGFi_j.d.ts +64 -0
- package/dist/document-type-patterns.d.ts +1 -0
- package/dist/document-type-patterns.js +14 -0
- package/dist/index.d.ts +459 -223
- package/dist/index.js +968 -468
- package/package.json +11 -1
package/dist/index.d.ts
CHANGED
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@@ -1,86 +1,171 @@
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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
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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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*/
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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"]>;
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declare const RiskGapCodeSchema: z.ZodEnum<["hazard_no_situation", "situation_no_harm", "hazard_not_analyzed", "missing_mitigation", "broken_mitigation_link", "control_not_approved", "missing_risk_benefit", "
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declare const RiskGapCodeSchema: z.ZodEnum<["hazard_no_situation", "situation_no_harm", "hazard_not_analyzed", "missing_mitigation", "broken_mitigation_link", "control_not_approved", "missing_risk_benefit", "risk_missing_safety_chain", "risk_broken_safety_chain", "wrong_probability_dimension", "missing_frontmatter", "requirement_no_architecture", "architecture_no_segregation", "architecture_no_parent", "haz_missing_category", "haz_invalid_category", "category_not_approved"]>;
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declare const RiskGapSeveritySchema: z.ZodEnum<["error", "warning"]>;
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declare const MitigationSchema: z.ZodObject<{
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control: z.ZodString;
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reduces: z.ZodEnum<["sequence_probability", "harm_probability", "severity"]>;
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for_harm: z.ZodOptional<z.ZodString>;
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}, "strip", z.ZodTypeAny, {
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control: string;
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reduces: "
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reduces: "sequence_probability" | "harm_probability" | "severity";
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for_harm?: string | undefined;
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}, {
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control: string;
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reduces: "
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reduces: "sequence_probability" | "harm_probability" | "severity";
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for_harm?: string | undefined;
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}>;
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declare const RiskEntryFrontmatterSchema: z.ZodObject<{
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declare const RiskEntryFrontmatterSchema: z.ZodEffects<z.ZodObject<{
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type: z.ZodEnum<["software_risk", "usability_risk", "security_risk"]>;
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id: z.ZodString;
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title: z.ZodString;
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status: z.ZodEnum<["draft", "in_review", "approved", "effective", "archived", "example"]>;
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analyzes: z.ZodString;
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hazardous_situation: z.ZodString;
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harm_assessments: z.ZodArray<z.ZodObject<{
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harm: z.ZodString;
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inherent_probability: z.ZodOptional<z.ZodNumber>;
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inherent_exploitability: z.ZodOptional<z.ZodNumber>;
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residual_probability: z.ZodOptional<z.ZodNumber>;
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residual_exploitability: z.ZodOptional<z.ZodNumber>;
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residual_severity_override: z.ZodOptional<z.ZodNumber>;
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}, "strip", z.ZodTypeAny, {
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harm: string;
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inherent_probability?: number | undefined;
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inherent_exploitability?: number | undefined;
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residual_probability?: number | undefined;
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residual_exploitability?: number | undefined;
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residual_severity_override?: number | undefined;
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}, {
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harm: string;
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inherent_probability?: number | undefined;
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inherent_exploitability?: number | undefined;
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residual_probability?: number | undefined;
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residual_exploitability?: number | undefined;
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residual_severity_override?: number | undefined;
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}>, "many">;
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mitigations: z.ZodOptional<z.ZodArray<z.ZodObject<{
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control: z.ZodString;
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reduces: z.ZodEnum<["sequence_probability", "harm_probability", "severity"]>;
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for_harm: z.ZodOptional<z.ZodString>;
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}, "strip", z.ZodTypeAny, {
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control: string;
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reduces: "
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reduces: "sequence_probability" | "harm_probability" | "severity";
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for_harm?: string | undefined;
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}, {
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control: string;
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reduces: "
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reduces: "sequence_probability" | "harm_probability" | "severity";
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for_harm?: string | undefined;
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}>, "many">>;
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residual_exploitability: z.ZodOptional<z.ZodNumber>;
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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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id: string;
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title: string;
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type: "usability_risk" | "software_risk" | "security_risk";
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status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
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hazardous_situation: string;
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harm: 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;
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inherent_exploitability?: number | undefined;
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residual_probability?: number | undefined;
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residual_exploitability?: number | undefined;
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residual_severity_override?: number | undefined;
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}[];
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mitigations?: {
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control: string;
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reduces: "
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reduces: "sequence_probability" | "harm_probability" | "severity";
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for_harm?: string | undefined;
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}[] | undefined;
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residual_severity?: number | undefined;
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residual_probability?: number | undefined;
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residual_exploitability?: number | undefined;
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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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id: string;
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title: string;
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status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
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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;
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inherent_exploitability?: number | undefined;
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residual_probability?: number | undefined;
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residual_exploitability?: number | undefined;
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residual_severity_override?: number | undefined;
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}[];
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mitigations?: {
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control: string;
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reduces: "sequence_probability" | "harm_probability" | "severity";
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for_harm?: string | undefined;
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}[] | undefined;
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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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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;
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inherent_exploitability?: number | undefined;
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residual_probability?: number | undefined;
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residual_exploitability?: number | undefined;
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residual_severity_override?: number | undefined;
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}[];
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mitigations?: {
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control: string;
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reduces: "
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reduces: "sequence_probability" | "harm_probability" | "severity";
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for_harm?: string | undefined;
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}[] | undefined;
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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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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;
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inherent_exploitability?: number | undefined;
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residual_probability?: number | undefined;
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residual_exploitability?: number | undefined;
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residual_severity_override?: number | undefined;
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}[];
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mitigations?: {
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control: string;
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reduces: "sequence_probability" | "harm_probability" | "severity";
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for_harm?: string | undefined;
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}[] | undefined;
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cvss_score?: number | undefined;
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cvss_vector?: string | undefined;
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}>;
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declare const HazardFrontmatterSchema: z.ZodObject<{
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type: z.ZodEnum<["haz_soe_software", "haz_soe_security"]>;
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@@ -93,49 +178,68 @@ declare const HazardFrontmatterSchema: z.ZodObject<{
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detection_method: z.ZodOptional<z.ZodString>;
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threat_category: z.ZodOptional<z.ZodString>;
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attack_vector: z.ZodOptional<z.ZodString>;
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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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id: string;
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title: string;
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type: "haz_soe_software" | "haz_soe_security";
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status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
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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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id: string;
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title: string;
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type: "haz_soe_software" | "haz_soe_security";
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status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
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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">;
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id: z.ZodString;
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title: z.ZodString;
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status: z.ZodEnum<["draft", "in_review", "approved", "effective", "archived", "example"]>;
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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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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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id: string;
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title: string;
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source?: string | undefined;
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}>;
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declare const HazardousSituationFrontmatterSchema: z.ZodObject<{
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type: z.ZodLiteral<"hazardous_situation">;
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id: z.ZodString;
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title: z.ZodString;
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status: z.ZodEnum<["draft", "in_review", "approved", "effective", "archived", "example"]>;
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probability: z.ZodNumber;
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type: "use_specification";
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author?: string | undefined;
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reviewers?: string[] | undefined;
|
|
@@ -308,32 +413,29 @@ declare const TaskAnalysisFrontmatterSchema: z.ZodObject<{
|
|
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status: z.ZodEnum<["draft", "in_review", "approved", "effective", "archived", "example"]>;
|
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user_group: z.ZodString;
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|
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|
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|
|
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|
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|
|
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|
+
type: "task_analysis";
|
|
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|
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status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
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|
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|
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|
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status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
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|
|
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|
critical_task: boolean;
|
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|
|
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|
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|
|
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|
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|
|
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|
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max_harm_severity?: number | undefined;
|
|
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|
}, {
|
|
430
|
+
type: "task_analysis";
|
|
431
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
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|
id: string;
|
|
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|
title: string;
|
|
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|
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type: "task_analysis";
|
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|
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status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
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|
user_group: string;
|
|
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|
critical_task: boolean;
|
|
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|
author?: string | undefined;
|
|
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|
reviewers?: string[] | undefined;
|
|
335
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|
approvers?: string[] | undefined;
|
|
336
|
-
max_harm_severity?: number | undefined;
|
|
337
439
|
}>;
|
|
338
440
|
declare const UsabilityEvaluationFrontmatterSchema: z.ZodObject<{
|
|
339
441
|
type: z.ZodLiteral<"usability_evaluation">;
|
|
@@ -345,19 +447,19 @@ declare const UsabilityEvaluationFrontmatterSchema: z.ZodObject<{
|
|
|
345
447
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
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|
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|
|
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|
}, "strip", z.ZodTypeAny, {
|
|
450
|
+
type: "usability_evaluation";
|
|
451
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
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|
id: string;
|
|
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|
title: string;
|
|
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|
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type: "usability_evaluation";
|
|
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|
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status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
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|
author?: string | undefined;
|
|
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455
|
reviewers?: string[] | undefined;
|
|
354
456
|
approvers?: string[] | undefined;
|
|
355
457
|
result?: "pass" | "fail" | "pass_with_findings" | undefined;
|
|
356
458
|
}, {
|
|
459
|
+
type: "usability_evaluation";
|
|
460
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
357
461
|
id: string;
|
|
358
462
|
title: string;
|
|
359
|
-
type: "usability_evaluation";
|
|
360
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
361
463
|
author?: string | undefined;
|
|
362
464
|
reviewers?: string[] | undefined;
|
|
363
465
|
approvers?: string[] | undefined;
|
|
@@ -373,19 +475,19 @@ declare const SummativeEvaluationFrontmatterSchema: z.ZodObject<{
|
|
|
373
475
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
374
476
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
375
477
|
}, "strip", z.ZodTypeAny, {
|
|
478
|
+
type: "summative_evaluation";
|
|
479
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
376
480
|
id: string;
|
|
377
481
|
title: string;
|
|
378
|
-
type: "summative_evaluation";
|
|
379
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
380
482
|
author?: string | undefined;
|
|
381
483
|
reviewers?: string[] | undefined;
|
|
382
484
|
approvers?: string[] | undefined;
|
|
383
485
|
result?: "pass" | "fail" | "pass_with_findings" | undefined;
|
|
384
486
|
}, {
|
|
487
|
+
type: "summative_evaluation";
|
|
488
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
385
489
|
id: string;
|
|
386
490
|
title: string;
|
|
387
|
-
type: "summative_evaluation";
|
|
388
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
389
491
|
author?: string | undefined;
|
|
390
492
|
reviewers?: string[] | undefined;
|
|
391
493
|
approvers?: string[] | undefined;
|
|
@@ -414,18 +516,18 @@ declare const RiskManagementPlanFrontmatterSchema: z.ZodObject<{
|
|
|
414
516
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
415
517
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
416
518
|
}, "strip", z.ZodTypeAny, {
|
|
519
|
+
type: "risk_management_plan";
|
|
520
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
417
521
|
id: string;
|
|
418
522
|
title: string;
|
|
419
|
-
type: "risk_management_plan";
|
|
420
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
421
523
|
author?: string | undefined;
|
|
422
524
|
reviewers?: string[] | undefined;
|
|
423
525
|
approvers?: string[] | undefined;
|
|
424
526
|
}, {
|
|
527
|
+
type: "risk_management_plan";
|
|
528
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
425
529
|
id: string;
|
|
426
530
|
title: string;
|
|
427
|
-
type: "risk_management_plan";
|
|
428
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
429
531
|
author?: string | undefined;
|
|
430
532
|
reviewers?: string[] | undefined;
|
|
431
533
|
approvers?: string[] | undefined;
|
|
@@ -445,18 +547,18 @@ declare const SoftwareDevelopmentPlanFrontmatterSchema: z.ZodObject<{
|
|
|
445
547
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
446
548
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
447
549
|
}, "strip", z.ZodTypeAny, {
|
|
550
|
+
type: "software_development_plan";
|
|
551
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
448
552
|
id: string;
|
|
449
553
|
title: string;
|
|
450
|
-
type: "software_development_plan";
|
|
451
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
452
554
|
author?: string | undefined;
|
|
453
555
|
reviewers?: string[] | undefined;
|
|
454
556
|
approvers?: string[] | undefined;
|
|
455
557
|
}, {
|
|
558
|
+
type: "software_development_plan";
|
|
559
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
456
560
|
id: string;
|
|
457
561
|
title: string;
|
|
458
|
-
type: "software_development_plan";
|
|
459
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
460
562
|
author?: string | undefined;
|
|
461
563
|
reviewers?: string[] | undefined;
|
|
462
564
|
approvers?: string[] | undefined;
|
|
@@ -470,18 +572,18 @@ declare const SoftwareMaintenancePlanFrontmatterSchema: z.ZodObject<{
|
|
|
470
572
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
471
573
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
472
574
|
}, "strip", z.ZodTypeAny, {
|
|
575
|
+
type: "software_maintenance_plan";
|
|
576
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
473
577
|
id: string;
|
|
474
578
|
title: string;
|
|
475
|
-
type: "software_maintenance_plan";
|
|
476
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
477
579
|
author?: string | undefined;
|
|
478
580
|
reviewers?: string[] | undefined;
|
|
479
581
|
approvers?: string[] | undefined;
|
|
480
582
|
}, {
|
|
583
|
+
type: "software_maintenance_plan";
|
|
584
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
481
585
|
id: string;
|
|
482
586
|
title: string;
|
|
483
|
-
type: "software_maintenance_plan";
|
|
484
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
485
587
|
author?: string | undefined;
|
|
486
588
|
reviewers?: string[] | undefined;
|
|
487
589
|
approvers?: string[] | undefined;
|
|
@@ -495,18 +597,43 @@ declare const SoupRegisterFrontmatterSchema: z.ZodObject<{
|
|
|
495
597
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
496
598
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
497
599
|
}, "strip", z.ZodTypeAny, {
|
|
600
|
+
type: "soup_register";
|
|
601
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
498
602
|
id: string;
|
|
499
603
|
title: string;
|
|
604
|
+
author?: string | undefined;
|
|
605
|
+
reviewers?: string[] | undefined;
|
|
606
|
+
approvers?: string[] | undefined;
|
|
607
|
+
}, {
|
|
500
608
|
type: "soup_register";
|
|
501
|
-
status: "draft" | "
|
|
609
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
610
|
+
id: string;
|
|
611
|
+
title: string;
|
|
612
|
+
author?: string | undefined;
|
|
613
|
+
reviewers?: string[] | undefined;
|
|
614
|
+
approvers?: string[] | undefined;
|
|
615
|
+
}>;
|
|
616
|
+
declare const SoftwareTestPlanFrontmatterSchema: z.ZodObject<{
|
|
617
|
+
type: z.ZodLiteral<"software_test_plan">;
|
|
618
|
+
id: z.ZodString;
|
|
619
|
+
title: z.ZodString;
|
|
620
|
+
status: z.ZodEnum<["draft", "in_review", "approved", "effective", "archived", "example"]>;
|
|
621
|
+
author: z.ZodOptional<z.ZodString>;
|
|
622
|
+
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
623
|
+
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
624
|
+
}, "strip", z.ZodTypeAny, {
|
|
625
|
+
type: "software_test_plan";
|
|
626
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
627
|
+
id: string;
|
|
628
|
+
title: string;
|
|
502
629
|
author?: string | undefined;
|
|
503
630
|
reviewers?: string[] | undefined;
|
|
504
631
|
approvers?: string[] | undefined;
|
|
505
632
|
}, {
|
|
633
|
+
type: "software_test_plan";
|
|
634
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
506
635
|
id: string;
|
|
507
636
|
title: string;
|
|
508
|
-
type: "soup_register";
|
|
509
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
510
637
|
author?: string | undefined;
|
|
511
638
|
reviewers?: string[] | undefined;
|
|
512
639
|
approvers?: string[] | undefined;
|
|
@@ -514,6 +641,7 @@ declare const SoupRegisterFrontmatterSchema: z.ZodObject<{
|
|
|
514
641
|
type SoftwareDevelopmentPlanFrontmatter = z.infer<typeof SoftwareDevelopmentPlanFrontmatterSchema>;
|
|
515
642
|
type SoftwareMaintenancePlanFrontmatter = z.infer<typeof SoftwareMaintenancePlanFrontmatterSchema>;
|
|
516
643
|
type SoupRegisterFrontmatter = z.infer<typeof SoupRegisterFrontmatterSchema>;
|
|
644
|
+
type SoftwareTestPlanFrontmatter = z.infer<typeof SoftwareTestPlanFrontmatterSchema>;
|
|
517
645
|
|
|
518
646
|
/**
|
|
519
647
|
* Zod schemas for IEC 62304 §9 Software Problem Resolution (Anomaly) document type.
|
|
@@ -538,24 +666,24 @@ declare const AnomalyFrontmatterSchema: z.ZodObject<{
|
|
|
538
666
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
539
667
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
540
668
|
}, "strip", z.ZodTypeAny, {
|
|
669
|
+
severity: "critical" | "major" | "minor";
|
|
670
|
+
type: "anomaly";
|
|
671
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
541
672
|
id: string;
|
|
542
673
|
title: string;
|
|
543
|
-
|
|
544
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
545
|
-
severity: "critical" | "major" | "minor";
|
|
546
|
-
category: "bug" | "regression" | "security_vulnerability" | "performance";
|
|
674
|
+
category: "performance" | "bug" | "security_vulnerability" | "regression";
|
|
547
675
|
disposition: "open" | "investigating" | "resolved" | "deferred" | "will_not_fix";
|
|
548
676
|
author?: string | undefined;
|
|
549
677
|
reviewers?: string[] | undefined;
|
|
550
678
|
approvers?: string[] | undefined;
|
|
551
679
|
affected_version?: string | undefined;
|
|
552
680
|
}, {
|
|
681
|
+
severity: "critical" | "major" | "minor";
|
|
682
|
+
type: "anomaly";
|
|
683
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
553
684
|
id: string;
|
|
554
685
|
title: string;
|
|
555
|
-
|
|
556
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
557
|
-
severity: "critical" | "major" | "minor";
|
|
558
|
-
category: "bug" | "regression" | "security_vulnerability" | "performance";
|
|
686
|
+
category: "performance" | "bug" | "security_vulnerability" | "regression";
|
|
559
687
|
disposition: "open" | "investigating" | "resolved" | "deferred" | "will_not_fix";
|
|
560
688
|
author?: string | undefined;
|
|
561
689
|
reviewers?: string[] | undefined;
|
|
@@ -580,18 +708,18 @@ declare const CybersecurityPlanFrontmatterSchema: z.ZodObject<{
|
|
|
580
708
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
581
709
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
582
710
|
}, "strip", z.ZodTypeAny, {
|
|
711
|
+
type: "cybersecurity_plan";
|
|
712
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
583
713
|
id: string;
|
|
584
714
|
title: string;
|
|
585
|
-
type: "cybersecurity_plan";
|
|
586
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
587
715
|
author?: string | undefined;
|
|
588
716
|
reviewers?: string[] | undefined;
|
|
589
717
|
approvers?: string[] | undefined;
|
|
590
718
|
}, {
|
|
719
|
+
type: "cybersecurity_plan";
|
|
720
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
591
721
|
id: string;
|
|
592
722
|
title: string;
|
|
593
|
-
type: "cybersecurity_plan";
|
|
594
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
595
723
|
author?: string | undefined;
|
|
596
724
|
reviewers?: string[] | undefined;
|
|
597
725
|
approvers?: string[] | undefined;
|
|
@@ -605,18 +733,18 @@ declare const SbomFrontmatterSchema: z.ZodObject<{
|
|
|
605
733
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
606
734
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
607
735
|
}, "strip", z.ZodTypeAny, {
|
|
736
|
+
type: "sbom";
|
|
737
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
608
738
|
id: string;
|
|
609
739
|
title: string;
|
|
610
|
-
type: "sbom";
|
|
611
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
612
740
|
author?: string | undefined;
|
|
613
741
|
reviewers?: string[] | undefined;
|
|
614
742
|
approvers?: string[] | undefined;
|
|
615
743
|
}, {
|
|
744
|
+
type: "sbom";
|
|
745
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
616
746
|
id: string;
|
|
617
747
|
title: string;
|
|
618
|
-
type: "sbom";
|
|
619
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
620
748
|
author?: string | undefined;
|
|
621
749
|
reviewers?: string[] | undefined;
|
|
622
750
|
approvers?: string[] | undefined;
|
|
@@ -637,18 +765,18 @@ declare const ClinicalEvaluationPlanFrontmatterSchema: z.ZodObject<{
|
|
|
637
765
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
638
766
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
639
767
|
}, "strip", z.ZodTypeAny, {
|
|
768
|
+
type: "clinical_evaluation_plan";
|
|
769
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
640
770
|
id: string;
|
|
641
771
|
title: string;
|
|
642
|
-
type: "clinical_evaluation_plan";
|
|
643
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
644
772
|
author?: string | undefined;
|
|
645
773
|
reviewers?: string[] | undefined;
|
|
646
774
|
approvers?: string[] | undefined;
|
|
647
775
|
}, {
|
|
776
|
+
type: "clinical_evaluation_plan";
|
|
777
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
648
778
|
id: string;
|
|
649
779
|
title: string;
|
|
650
|
-
type: "clinical_evaluation_plan";
|
|
651
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
652
780
|
author?: string | undefined;
|
|
653
781
|
reviewers?: string[] | undefined;
|
|
654
782
|
approvers?: string[] | undefined;
|
|
@@ -662,18 +790,18 @@ declare const ClinicalEvaluationReportFrontmatterSchema: z.ZodObject<{
|
|
|
662
790
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
663
791
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
664
792
|
}, "strip", z.ZodTypeAny, {
|
|
793
|
+
type: "clinical_evaluation_report";
|
|
794
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
665
795
|
id: string;
|
|
666
796
|
title: string;
|
|
667
|
-
type: "clinical_evaluation_report";
|
|
668
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
669
797
|
author?: string | undefined;
|
|
670
798
|
reviewers?: string[] | undefined;
|
|
671
799
|
approvers?: string[] | undefined;
|
|
672
800
|
}, {
|
|
801
|
+
type: "clinical_evaluation_report";
|
|
802
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
673
803
|
id: string;
|
|
674
804
|
title: string;
|
|
675
|
-
type: "clinical_evaluation_report";
|
|
676
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
677
805
|
author?: string | undefined;
|
|
678
806
|
reviewers?: string[] | undefined;
|
|
679
807
|
approvers?: string[] | undefined;
|
|
@@ -694,18 +822,18 @@ declare const PostMarketSurveillancePlanFrontmatterSchema: z.ZodObject<{
|
|
|
694
822
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
695
823
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
696
824
|
}, "strip", z.ZodTypeAny, {
|
|
825
|
+
type: "post_market_surveillance_plan";
|
|
826
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
697
827
|
id: string;
|
|
698
828
|
title: string;
|
|
699
|
-
type: "post_market_surveillance_plan";
|
|
700
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
701
829
|
author?: string | undefined;
|
|
702
830
|
reviewers?: string[] | undefined;
|
|
703
831
|
approvers?: string[] | undefined;
|
|
704
832
|
}, {
|
|
833
|
+
type: "post_market_surveillance_plan";
|
|
834
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
705
835
|
id: string;
|
|
706
836
|
title: string;
|
|
707
|
-
type: "post_market_surveillance_plan";
|
|
708
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
709
837
|
author?: string | undefined;
|
|
710
838
|
reviewers?: string[] | undefined;
|
|
711
839
|
approvers?: string[] | undefined;
|
|
@@ -726,11 +854,11 @@ declare const PostMarketFeedbackFrontmatterSchema: z.ZodObject<{
|
|
|
726
854
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
727
855
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
728
856
|
}, "strip", z.ZodTypeAny, {
|
|
857
|
+
severity: "low" | "medium" | "high" | "critical";
|
|
858
|
+
type: "post_market_feedback";
|
|
859
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
729
860
|
id: string;
|
|
730
861
|
title: string;
|
|
731
|
-
type: "post_market_feedback";
|
|
732
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
733
|
-
severity: "critical" | "low" | "medium" | "high";
|
|
734
862
|
category: "complaint" | "field_observation" | "clinical_followup" | "trend_report";
|
|
735
863
|
author?: string | undefined;
|
|
736
864
|
reviewers?: string[] | undefined;
|
|
@@ -738,11 +866,11 @@ declare const PostMarketFeedbackFrontmatterSchema: z.ZodObject<{
|
|
|
738
866
|
device?: string | undefined;
|
|
739
867
|
reporting_period?: string | undefined;
|
|
740
868
|
}, {
|
|
869
|
+
severity: "low" | "medium" | "high" | "critical";
|
|
870
|
+
type: "post_market_feedback";
|
|
871
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
741
872
|
id: string;
|
|
742
873
|
title: string;
|
|
743
|
-
type: "post_market_feedback";
|
|
744
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
745
|
-
severity: "critical" | "low" | "medium" | "high";
|
|
746
874
|
category: "complaint" | "field_observation" | "clinical_followup" | "trend_report";
|
|
747
875
|
author?: string | undefined;
|
|
748
876
|
reviewers?: string[] | undefined;
|
|
@@ -766,19 +894,19 @@ declare const LabelingFrontmatterSchema: z.ZodObject<{
|
|
|
766
894
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
767
895
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
768
896
|
}, "strip", z.ZodTypeAny, {
|
|
897
|
+
type: "labeling";
|
|
898
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
769
899
|
id: string;
|
|
770
900
|
title: string;
|
|
771
|
-
type: "labeling";
|
|
772
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
773
901
|
author?: string | undefined;
|
|
774
902
|
reviewers?: string[] | undefined;
|
|
775
903
|
approvers?: string[] | undefined;
|
|
776
904
|
label_type?: "ifu" | "product_label" | "packaging_label" | undefined;
|
|
777
905
|
}, {
|
|
906
|
+
type: "labeling";
|
|
907
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
778
908
|
id: string;
|
|
779
909
|
title: string;
|
|
780
|
-
type: "labeling";
|
|
781
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
782
910
|
author?: string | undefined;
|
|
783
911
|
reviewers?: string[] | undefined;
|
|
784
912
|
approvers?: string[] | undefined;
|
|
@@ -799,18 +927,18 @@ declare const ProductDevelopmentPlanFrontmatterSchema: z.ZodObject<{
|
|
|
799
927
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
800
928
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
801
929
|
}, "strip", z.ZodTypeAny, {
|
|
930
|
+
type: "product_development_plan";
|
|
931
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
802
932
|
id: string;
|
|
803
933
|
title: string;
|
|
804
|
-
type: "product_development_plan";
|
|
805
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
806
934
|
author?: string | undefined;
|
|
807
935
|
reviewers?: string[] | undefined;
|
|
808
936
|
approvers?: string[] | undefined;
|
|
809
937
|
}, {
|
|
938
|
+
type: "product_development_plan";
|
|
939
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
810
940
|
id: string;
|
|
811
941
|
title: string;
|
|
812
|
-
type: "product_development_plan";
|
|
813
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
814
942
|
author?: string | undefined;
|
|
815
943
|
reviewers?: string[] | undefined;
|
|
816
944
|
approvers?: string[] | undefined;
|
|
@@ -824,18 +952,18 @@ declare const IntendedUseFrontmatterSchema: z.ZodObject<{
|
|
|
824
952
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
825
953
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
826
954
|
}, "strip", z.ZodTypeAny, {
|
|
955
|
+
type: "intended_use";
|
|
956
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
827
957
|
id: string;
|
|
828
958
|
title: string;
|
|
829
|
-
type: "intended_use";
|
|
830
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
831
959
|
author?: string | undefined;
|
|
832
960
|
reviewers?: string[] | undefined;
|
|
833
961
|
approvers?: string[] | undefined;
|
|
834
962
|
}, {
|
|
963
|
+
type: "intended_use";
|
|
964
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
835
965
|
id: string;
|
|
836
966
|
title: string;
|
|
837
|
-
type: "intended_use";
|
|
838
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
839
967
|
author?: string | undefined;
|
|
840
968
|
reviewers?: string[] | undefined;
|
|
841
969
|
approvers?: string[] | undefined;
|
|
@@ -877,29 +1005,29 @@ declare const UserNeedFrontmatterSchema: z.ZodObject<{
|
|
|
877
1005
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
878
1006
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
879
1007
|
}, "strip", z.ZodTypeAny, {
|
|
1008
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
880
1009
|
id: string;
|
|
881
1010
|
title: string;
|
|
882
|
-
status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
|
|
883
1011
|
type?: "user_need" | undefined;
|
|
884
|
-
stakeholder?: string | undefined;
|
|
885
|
-
priority?: "must_have" | "should_have" | "nice_to_have" | undefined;
|
|
886
1012
|
source?: string | undefined;
|
|
887
|
-
derives?: string[] | undefined;
|
|
888
1013
|
author?: string | undefined;
|
|
889
1014
|
reviewers?: string[] | undefined;
|
|
890
1015
|
approvers?: string[] | undefined;
|
|
1016
|
+
stakeholder?: string | undefined;
|
|
1017
|
+
priority?: "must_have" | "should_have" | "nice_to_have" | undefined;
|
|
1018
|
+
derives?: string[] | undefined;
|
|
891
1019
|
}, {
|
|
1020
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
892
1021
|
id: string;
|
|
893
1022
|
title: string;
|
|
894
|
-
status: "draft" | "in_review" | "approved" | "example" | "effective" | "archived";
|
|
895
1023
|
type?: "user_need" | undefined;
|
|
896
|
-
stakeholder?: string | undefined;
|
|
897
|
-
priority?: "must_have" | "should_have" | "nice_to_have" | undefined;
|
|
898
1024
|
source?: string | undefined;
|
|
899
|
-
derives?: string[] | undefined;
|
|
900
1025
|
author?: string | undefined;
|
|
901
1026
|
reviewers?: string[] | undefined;
|
|
902
1027
|
approvers?: string[] | undefined;
|
|
1028
|
+
stakeholder?: string | undefined;
|
|
1029
|
+
priority?: "must_have" | "should_have" | "nice_to_have" | undefined;
|
|
1030
|
+
derives?: string[] | undefined;
|
|
903
1031
|
}>;
|
|
904
1032
|
type UserNeedPriority = z.infer<typeof UserNeedPrioritySchema>;
|
|
905
1033
|
type UserNeedFrontmatter = z.infer<typeof UserNeedFrontmatterSchema>;
|
|
@@ -949,26 +1077,34 @@ declare const RequirementFrontmatterSchema: z.ZodObject<{
|
|
|
949
1077
|
author: z.ZodOptional<z.ZodString>;
|
|
950
1078
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
951
1079
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
1080
|
+
/** Upstream traceability — IDs of documents this requirement traces from (e.g., UN for PRS, PRS for SRS) */
|
|
1081
|
+
traces_from: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
1082
|
+
/** Downstream traceability — IDs of documents this requirement traces to (e.g., SRS for PRS) */
|
|
1083
|
+
traces_to: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
952
1084
|
}, "strip", z.ZodTypeAny, {
|
|
1085
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
953
1086
|
id: string;
|
|
954
1087
|
title: string;
|
|
955
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
956
1088
|
author?: string | undefined;
|
|
957
1089
|
reviewers?: string[] | undefined;
|
|
958
1090
|
approvers?: string[] | undefined;
|
|
959
|
-
req_type?: "
|
|
1091
|
+
req_type?: "safety" | "performance" | "usability" | "regulatory" | "functional" | "interface" | "security" | undefined;
|
|
960
1092
|
format?: "standard" | "user_story" | undefined;
|
|
961
1093
|
fulfillment_type?: "labeling" | "usability" | "software" | "clinical" | "regulatory_doc" | "process" | undefined;
|
|
1094
|
+
traces_from?: string[] | undefined;
|
|
1095
|
+
traces_to?: string[] | undefined;
|
|
962
1096
|
}, {
|
|
1097
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
963
1098
|
id: string;
|
|
964
1099
|
title: string;
|
|
965
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
966
1100
|
author?: string | undefined;
|
|
967
1101
|
reviewers?: string[] | undefined;
|
|
968
1102
|
approvers?: string[] | undefined;
|
|
969
|
-
req_type?: "
|
|
1103
|
+
req_type?: "safety" | "performance" | "usability" | "regulatory" | "functional" | "interface" | "security" | undefined;
|
|
970
1104
|
format?: "standard" | "user_story" | undefined;
|
|
971
1105
|
fulfillment_type?: "labeling" | "usability" | "software" | "clinical" | "regulatory_doc" | "process" | undefined;
|
|
1106
|
+
traces_from?: string[] | undefined;
|
|
1107
|
+
traces_to?: string[] | undefined;
|
|
972
1108
|
}>;
|
|
973
1109
|
type RequirementType = z.infer<typeof RequirementTypeSchema>;
|
|
974
1110
|
type RequirementFormat = z.infer<typeof RequirementFormatSchema>;
|
|
@@ -988,18 +1124,18 @@ declare const TestProtocolFrontmatterSchema: z.ZodObject<{
|
|
|
988
1124
|
reviewers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
989
1125
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
990
1126
|
}, "strip", z.ZodTypeAny, {
|
|
1127
|
+
type: "test_protocol";
|
|
1128
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
991
1129
|
id: string;
|
|
992
1130
|
title: string;
|
|
993
|
-
type: "test_protocol";
|
|
994
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
995
1131
|
author?: string | undefined;
|
|
996
1132
|
reviewers?: string[] | undefined;
|
|
997
1133
|
approvers?: string[] | undefined;
|
|
998
1134
|
}, {
|
|
1135
|
+
type: "test_protocol";
|
|
1136
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
999
1137
|
id: string;
|
|
1000
1138
|
title: string;
|
|
1001
|
-
type: "test_protocol";
|
|
1002
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
1003
1139
|
author?: string | undefined;
|
|
1004
1140
|
reviewers?: string[] | undefined;
|
|
1005
1141
|
approvers?: string[] | undefined;
|
|
@@ -1016,20 +1152,20 @@ declare const TestReportFrontmatterSchema: z.ZodObject<{
|
|
|
1016
1152
|
release_version: z.ZodOptional<z.ZodString>;
|
|
1017
1153
|
test_phase: z.ZodOptional<z.ZodEnum<["verification", "production"]>>;
|
|
1018
1154
|
}, "strip", z.ZodTypeAny, {
|
|
1155
|
+
type: "test_report";
|
|
1156
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
1019
1157
|
id: string;
|
|
1020
1158
|
title: string;
|
|
1021
|
-
type: "test_report";
|
|
1022
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
1023
1159
|
author?: string | undefined;
|
|
1024
1160
|
reviewers?: string[] | undefined;
|
|
1025
1161
|
approvers?: string[] | undefined;
|
|
1026
1162
|
release_version?: string | undefined;
|
|
1027
1163
|
test_phase?: "verification" | "production" | undefined;
|
|
1028
1164
|
}, {
|
|
1165
|
+
type: "test_report";
|
|
1166
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
1029
1167
|
id: string;
|
|
1030
1168
|
title: string;
|
|
1031
|
-
type: "test_report";
|
|
1032
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
1033
1169
|
author?: string | undefined;
|
|
1034
1170
|
reviewers?: string[] | undefined;
|
|
1035
1171
|
approvers?: string[] | undefined;
|
|
@@ -1076,16 +1212,16 @@ declare const RepoConfigSchema: z.ZodObject<{
|
|
|
1076
1212
|
}>>;
|
|
1077
1213
|
udi_device_identifier: z.ZodOptional<z.ZodString>;
|
|
1078
1214
|
}, "strip", z.ZodTypeAny, {
|
|
1079
|
-
name: string;
|
|
1080
1215
|
safety_class: "A" | "B" | "C";
|
|
1216
|
+
name: string;
|
|
1081
1217
|
classification?: {
|
|
1082
1218
|
eu?: string | undefined;
|
|
1083
1219
|
us?: string | undefined;
|
|
1084
1220
|
} | undefined;
|
|
1085
1221
|
udi_device_identifier?: string | undefined;
|
|
1086
1222
|
}, {
|
|
1087
|
-
name: string;
|
|
1088
1223
|
safety_class: "A" | "B" | "C";
|
|
1224
|
+
name: string;
|
|
1089
1225
|
classification?: {
|
|
1090
1226
|
eu?: string | undefined;
|
|
1091
1227
|
us?: string | undefined;
|
|
@@ -1104,8 +1240,8 @@ declare const RepoConfigSchema: z.ZodObject<{
|
|
|
1104
1240
|
}>>;
|
|
1105
1241
|
}, "strip", z.ZodTypeAny, {
|
|
1106
1242
|
device: {
|
|
1107
|
-
name: string;
|
|
1108
1243
|
safety_class: "A" | "B" | "C";
|
|
1244
|
+
name: string;
|
|
1109
1245
|
classification?: {
|
|
1110
1246
|
eu?: string | undefined;
|
|
1111
1247
|
us?: string | undefined;
|
|
@@ -1118,8 +1254,8 @@ declare const RepoConfigSchema: z.ZodObject<{
|
|
|
1118
1254
|
} | undefined;
|
|
1119
1255
|
}, {
|
|
1120
1256
|
device: {
|
|
1121
|
-
name: string;
|
|
1122
1257
|
safety_class: "A" | "B" | "C";
|
|
1258
|
+
name: string;
|
|
1123
1259
|
classification?: {
|
|
1124
1260
|
eu?: string | undefined;
|
|
1125
1261
|
us?: string | undefined;
|
|
@@ -1156,20 +1292,20 @@ declare const ReleasePlanFrontmatterSchema: z.ZodObject<{
|
|
|
1156
1292
|
title: string;
|
|
1157
1293
|
type?: "release_plan" | undefined;
|
|
1158
1294
|
status?: string | undefined;
|
|
1295
|
+
version?: string | undefined;
|
|
1159
1296
|
author?: string | undefined;
|
|
1160
1297
|
reviewers?: string[] | undefined;
|
|
1161
1298
|
approvers?: string[] | undefined;
|
|
1162
|
-
version?: string | undefined;
|
|
1163
1299
|
target_date?: string | undefined;
|
|
1164
1300
|
}, {
|
|
1165
1301
|
id: string;
|
|
1166
1302
|
title: string;
|
|
1167
1303
|
type?: "release_plan" | undefined;
|
|
1168
1304
|
status?: string | undefined;
|
|
1305
|
+
version?: string | undefined;
|
|
1169
1306
|
author?: string | undefined;
|
|
1170
1307
|
reviewers?: string[] | undefined;
|
|
1171
1308
|
approvers?: string[] | undefined;
|
|
1172
|
-
version?: string | undefined;
|
|
1173
1309
|
target_date?: string | undefined;
|
|
1174
1310
|
}>;
|
|
1175
1311
|
type ReleasePlanFrontmatter = z.infer<typeof ReleasePlanFrontmatterSchema>;
|
|
@@ -1183,6 +1319,43 @@ declare const DesignReviewFrontmatterSchema: z.ZodObject<{
|
|
|
1183
1319
|
approvers: z.ZodOptional<z.ZodArray<z.ZodString, "many">>;
|
|
1184
1320
|
/** Optional link to a Release Plan document (e.g. "RP-001") */
|
|
1185
1321
|
release_plan: z.ZodOptional<z.ZodString>;
|
|
1322
|
+
/** Acknowledged suspected links — one-up/one-down neighbor analysis */
|
|
1323
|
+
suspected_links: z.ZodOptional<z.ZodArray<z.ZodObject<{
|
|
1324
|
+
triggered_by: z.ZodString;
|
|
1325
|
+
neighbors: z.ZodArray<z.ZodObject<{
|
|
1326
|
+
document: z.ZodString;
|
|
1327
|
+
direction: z.ZodEnum<["upstream", "downstream"]>;
|
|
1328
|
+
disposition: z.ZodEnum<["included_in_release", "not_impacted"]>;
|
|
1329
|
+
/** Required when disposition is 'not_impacted' */
|
|
1330
|
+
rationale: z.ZodOptional<z.ZodString>;
|
|
1331
|
+
}, "strip", z.ZodTypeAny, {
|
|
1332
|
+
disposition: "included_in_release" | "not_impacted";
|
|
1333
|
+
document: string;
|
|
1334
|
+
direction: "upstream" | "downstream";
|
|
1335
|
+
rationale?: string | undefined;
|
|
1336
|
+
}, {
|
|
1337
|
+
disposition: "included_in_release" | "not_impacted";
|
|
1338
|
+
document: string;
|
|
1339
|
+
direction: "upstream" | "downstream";
|
|
1340
|
+
rationale?: string | undefined;
|
|
1341
|
+
}>, "many">;
|
|
1342
|
+
}, "strip", z.ZodTypeAny, {
|
|
1343
|
+
triggered_by: string;
|
|
1344
|
+
neighbors: {
|
|
1345
|
+
disposition: "included_in_release" | "not_impacted";
|
|
1346
|
+
document: string;
|
|
1347
|
+
direction: "upstream" | "downstream";
|
|
1348
|
+
rationale?: string | undefined;
|
|
1349
|
+
}[];
|
|
1350
|
+
}, {
|
|
1351
|
+
triggered_by: string;
|
|
1352
|
+
neighbors: {
|
|
1353
|
+
disposition: "included_in_release" | "not_impacted";
|
|
1354
|
+
document: string;
|
|
1355
|
+
direction: "upstream" | "downstream";
|
|
1356
|
+
rationale?: string | undefined;
|
|
1357
|
+
}[];
|
|
1358
|
+
}>, "many">>;
|
|
1186
1359
|
}, "strip", z.ZodTypeAny, {
|
|
1187
1360
|
id: string;
|
|
1188
1361
|
title: string;
|
|
@@ -1192,6 +1365,15 @@ declare const DesignReviewFrontmatterSchema: z.ZodObject<{
|
|
|
1192
1365
|
reviewers?: string[] | undefined;
|
|
1193
1366
|
approvers?: string[] | undefined;
|
|
1194
1367
|
release_plan?: string | undefined;
|
|
1368
|
+
suspected_links?: {
|
|
1369
|
+
triggered_by: string;
|
|
1370
|
+
neighbors: {
|
|
1371
|
+
disposition: "included_in_release" | "not_impacted";
|
|
1372
|
+
document: string;
|
|
1373
|
+
direction: "upstream" | "downstream";
|
|
1374
|
+
rationale?: string | undefined;
|
|
1375
|
+
}[];
|
|
1376
|
+
}[] | undefined;
|
|
1195
1377
|
}, {
|
|
1196
1378
|
id: string;
|
|
1197
1379
|
title: string;
|
|
@@ -1201,6 +1383,15 @@ declare const DesignReviewFrontmatterSchema: z.ZodObject<{
|
|
|
1201
1383
|
reviewers?: string[] | undefined;
|
|
1202
1384
|
approvers?: string[] | undefined;
|
|
1203
1385
|
release_plan?: string | undefined;
|
|
1386
|
+
suspected_links?: {
|
|
1387
|
+
triggered_by: string;
|
|
1388
|
+
neighbors: {
|
|
1389
|
+
disposition: "included_in_release" | "not_impacted";
|
|
1390
|
+
document: string;
|
|
1391
|
+
direction: "upstream" | "downstream";
|
|
1392
|
+
rationale?: string | undefined;
|
|
1393
|
+
}[];
|
|
1394
|
+
}[] | undefined;
|
|
1204
1395
|
}>;
|
|
1205
1396
|
type DesignReviewFrontmatter = z.infer<typeof DesignReviewFrontmatterSchema>;
|
|
1206
1397
|
declare const ReleaseNotesAudienceSchema: z.ZodEnum<["customer", "technical"]>;
|
|
@@ -1216,21 +1407,21 @@ declare const ReleaseNotesFrontmatterSchema: z.ZodObject<{
|
|
|
1216
1407
|
audience: z.ZodEnum<["customer", "technical"]>;
|
|
1217
1408
|
release_version: z.ZodString;
|
|
1218
1409
|
}, "strip", z.ZodTypeAny, {
|
|
1410
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
1219
1411
|
id: string;
|
|
1220
1412
|
title: string;
|
|
1221
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
1222
|
-
audience: "customer" | "technical";
|
|
1223
1413
|
release_version: string;
|
|
1414
|
+
audience: "customer" | "technical";
|
|
1224
1415
|
type?: "release_notes" | undefined;
|
|
1225
1416
|
author?: string | undefined;
|
|
1226
1417
|
reviewers?: string[] | undefined;
|
|
1227
1418
|
approvers?: string[] | undefined;
|
|
1228
1419
|
}, {
|
|
1420
|
+
status: "draft" | "in_review" | "approved" | "effective" | "archived" | "example";
|
|
1229
1421
|
id: string;
|
|
1230
1422
|
title: string;
|
|
1231
|
-
status: "draft" | "approved" | "in_review" | "effective" | "archived" | "example";
|
|
1232
|
-
audience: "customer" | "technical";
|
|
1233
1423
|
release_version: string;
|
|
1424
|
+
audience: "customer" | "technical";
|
|
1234
1425
|
type?: "release_notes" | undefined;
|
|
1235
1426
|
author?: string | undefined;
|
|
1236
1427
|
reviewers?: string[] | undefined;
|
|
@@ -1306,18 +1497,18 @@ declare const PlannedAuditEntrySchema: z.ZodObject<{
|
|
|
1306
1497
|
auditor: z.ZodString;
|
|
1307
1498
|
status: z.ZodEnum<["planned", "in_progress", "completed", "cancelled"]>;
|
|
1308
1499
|
}, "strip", z.ZodTypeAny, {
|
|
1500
|
+
auditor: string;
|
|
1501
|
+
status: "in_progress" | "completed" | "cancelled" | "planned";
|
|
1309
1502
|
audit_id: string;
|
|
1310
1503
|
process_area: string;
|
|
1311
1504
|
planned_date: string;
|
|
1312
|
-
auditor: string;
|
|
1313
|
-
status: "planned" | "in_progress" | "completed" | "cancelled";
|
|
1314
1505
|
clause?: string | undefined;
|
|
1315
1506
|
}, {
|
|
1507
|
+
auditor: string;
|
|
1508
|
+
status: "in_progress" | "completed" | "cancelled" | "planned";
|
|
1316
1509
|
audit_id: string;
|
|
1317
1510
|
process_area: string;
|
|
1318
1511
|
planned_date: string;
|
|
1319
|
-
auditor: string;
|
|
1320
|
-
status: "planned" | "in_progress" | "completed" | "cancelled";
|
|
1321
1512
|
clause?: string | undefined;
|
|
1322
1513
|
}>;
|
|
1323
1514
|
type PlannedAuditEntry = z.infer<typeof PlannedAuditEntrySchema>;
|
|
@@ -1338,18 +1529,18 @@ declare const AuditScheduleFrontmatterSchema: z.ZodObject<{
|
|
|
1338
1529
|
auditor: z.ZodString;
|
|
1339
1530
|
status: z.ZodEnum<["planned", "in_progress", "completed", "cancelled"]>;
|
|
1340
1531
|
}, "strip", z.ZodTypeAny, {
|
|
1532
|
+
auditor: string;
|
|
1533
|
+
status: "in_progress" | "completed" | "cancelled" | "planned";
|
|
1341
1534
|
audit_id: string;
|
|
1342
1535
|
process_area: string;
|
|
1343
1536
|
planned_date: string;
|
|
1344
|
-
auditor: string;
|
|
1345
|
-
status: "planned" | "in_progress" | "completed" | "cancelled";
|
|
1346
1537
|
clause?: string | undefined;
|
|
1347
1538
|
}, {
|
|
1539
|
+
auditor: string;
|
|
1540
|
+
status: "in_progress" | "completed" | "cancelled" | "planned";
|
|
1348
1541
|
audit_id: string;
|
|
1349
1542
|
process_area: string;
|
|
1350
1543
|
planned_date: string;
|
|
1351
|
-
auditor: string;
|
|
1352
|
-
status: "planned" | "in_progress" | "completed" | "cancelled";
|
|
1353
1544
|
clause?: string | undefined;
|
|
1354
1545
|
}>, "many">;
|
|
1355
1546
|
}, "strip", z.ZodTypeAny, {
|
|
@@ -1357,15 +1548,15 @@ declare const AuditScheduleFrontmatterSchema: z.ZodObject<{
|
|
|
1357
1548
|
title: string;
|
|
1358
1549
|
cycle_year: number;
|
|
1359
1550
|
audits: {
|
|
1551
|
+
auditor: string;
|
|
1552
|
+
status: "in_progress" | "completed" | "cancelled" | "planned";
|
|
1360
1553
|
audit_id: string;
|
|
1361
1554
|
process_area: string;
|
|
1362
1555
|
planned_date: string;
|
|
1363
|
-
auditor: string;
|
|
1364
|
-
status: "planned" | "in_progress" | "completed" | "cancelled";
|
|
1365
1556
|
clause?: string | undefined;
|
|
1366
1557
|
}[];
|
|
1367
|
-
status?: string | undefined;
|
|
1368
1558
|
type?: "audit_schedule" | undefined;
|
|
1559
|
+
status?: string | undefined;
|
|
1369
1560
|
author?: string | undefined;
|
|
1370
1561
|
reviewers?: string[] | undefined;
|
|
1371
1562
|
approvers?: string[] | undefined;
|
|
@@ -1374,15 +1565,15 @@ declare const AuditScheduleFrontmatterSchema: z.ZodObject<{
|
|
|
1374
1565
|
title: string;
|
|
1375
1566
|
cycle_year: number;
|
|
1376
1567
|
audits: {
|
|
1568
|
+
auditor: string;
|
|
1569
|
+
status: "in_progress" | "completed" | "cancelled" | "planned";
|
|
1377
1570
|
audit_id: string;
|
|
1378
1571
|
process_area: string;
|
|
1379
1572
|
planned_date: string;
|
|
1380
|
-
auditor: string;
|
|
1381
|
-
status: "planned" | "in_progress" | "completed" | "cancelled";
|
|
1382
1573
|
clause?: string | undefined;
|
|
1383
1574
|
}[];
|
|
1384
|
-
status?: string | undefined;
|
|
1385
1575
|
type?: "audit_schedule" | undefined;
|
|
1576
|
+
status?: string | undefined;
|
|
1386
1577
|
author?: string | undefined;
|
|
1387
1578
|
reviewers?: string[] | undefined;
|
|
1388
1579
|
approvers?: string[] | undefined;
|
|
@@ -1394,13 +1585,13 @@ declare const AuditFindingSchema: z.ZodObject<{
|
|
|
1394
1585
|
description: z.ZodString;
|
|
1395
1586
|
capa_id: z.ZodOptional<z.ZodString>;
|
|
1396
1587
|
}, "strip", z.ZodTypeAny, {
|
|
1397
|
-
finding_id: string;
|
|
1398
1588
|
classification: "observation" | "minor_nc" | "major_nc";
|
|
1589
|
+
finding_id: string;
|
|
1399
1590
|
description: string;
|
|
1400
1591
|
capa_id?: string | undefined;
|
|
1401
1592
|
}, {
|
|
1402
|
-
finding_id: string;
|
|
1403
1593
|
classification: "observation" | "minor_nc" | "major_nc";
|
|
1594
|
+
finding_id: string;
|
|
1404
1595
|
description: string;
|
|
1405
1596
|
capa_id?: string | undefined;
|
|
1406
1597
|
}>;
|
|
@@ -1424,13 +1615,13 @@ declare const AuditReportFrontmatterSchema: z.ZodObject<{
|
|
|
1424
1615
|
description: z.ZodString;
|
|
1425
1616
|
capa_id: z.ZodOptional<z.ZodString>;
|
|
1426
1617
|
}, "strip", z.ZodTypeAny, {
|
|
1427
|
-
finding_id: string;
|
|
1428
1618
|
classification: "observation" | "minor_nc" | "major_nc";
|
|
1619
|
+
finding_id: string;
|
|
1429
1620
|
description: string;
|
|
1430
1621
|
capa_id?: string | undefined;
|
|
1431
1622
|
}, {
|
|
1432
|
-
finding_id: string;
|
|
1433
1623
|
classification: "observation" | "minor_nc" | "major_nc";
|
|
1624
|
+
finding_id: string;
|
|
1434
1625
|
description: string;
|
|
1435
1626
|
capa_id?: string | undefined;
|
|
1436
1627
|
}>, "many">;
|
|
@@ -1438,46 +1629,46 @@ declare const AuditReportFrontmatterSchema: z.ZodObject<{
|
|
|
1438
1629
|
findings_minor: z.ZodOptional<z.ZodNumber>;
|
|
1439
1630
|
findings_observations: z.ZodOptional<z.ZodNumber>;
|
|
1440
1631
|
}, "strip", z.ZodTypeAny, {
|
|
1441
|
-
process_area: string;
|
|
1442
1632
|
auditor: string;
|
|
1443
1633
|
id: string;
|
|
1444
1634
|
title: string;
|
|
1635
|
+
process_area: string;
|
|
1445
1636
|
audit_date: string;
|
|
1446
1637
|
findings: {
|
|
1447
|
-
finding_id: string;
|
|
1448
1638
|
classification: "observation" | "minor_nc" | "major_nc";
|
|
1639
|
+
finding_id: string;
|
|
1449
1640
|
description: string;
|
|
1450
1641
|
capa_id?: string | undefined;
|
|
1451
1642
|
}[];
|
|
1452
|
-
audit_id?: string | undefined;
|
|
1453
|
-
clause?: string | undefined;
|
|
1454
|
-
status?: string | undefined;
|
|
1455
1643
|
type?: "audit_report" | undefined;
|
|
1644
|
+
status?: string | undefined;
|
|
1456
1645
|
author?: string | undefined;
|
|
1457
1646
|
reviewers?: string[] | undefined;
|
|
1458
1647
|
approvers?: string[] | undefined;
|
|
1648
|
+
audit_id?: string | undefined;
|
|
1649
|
+
clause?: string | undefined;
|
|
1459
1650
|
findings_major?: number | undefined;
|
|
1460
1651
|
findings_minor?: number | undefined;
|
|
1461
1652
|
findings_observations?: number | undefined;
|
|
1462
1653
|
}, {
|
|
1463
|
-
process_area: string;
|
|
1464
1654
|
auditor: string;
|
|
1465
1655
|
id: string;
|
|
1466
1656
|
title: string;
|
|
1657
|
+
process_area: string;
|
|
1467
1658
|
audit_date: string;
|
|
1468
1659
|
findings: {
|
|
1469
|
-
finding_id: string;
|
|
1470
1660
|
classification: "observation" | "minor_nc" | "major_nc";
|
|
1661
|
+
finding_id: string;
|
|
1471
1662
|
description: string;
|
|
1472
1663
|
capa_id?: string | undefined;
|
|
1473
1664
|
}[];
|
|
1474
|
-
audit_id?: string | undefined;
|
|
1475
|
-
clause?: string | undefined;
|
|
1476
|
-
status?: string | undefined;
|
|
1477
1665
|
type?: "audit_report" | undefined;
|
|
1666
|
+
status?: string | undefined;
|
|
1478
1667
|
author?: string | undefined;
|
|
1479
1668
|
reviewers?: string[] | undefined;
|
|
1480
1669
|
approvers?: string[] | undefined;
|
|
1670
|
+
audit_id?: string | undefined;
|
|
1671
|
+
clause?: string | undefined;
|
|
1481
1672
|
findings_major?: number | undefined;
|
|
1482
1673
|
findings_minor?: number | undefined;
|
|
1483
1674
|
findings_observations?: number | undefined;
|
|
@@ -1506,11 +1697,11 @@ declare const ManagementReviewFrontmatterSchema: z.ZodObject<{
|
|
|
1506
1697
|
from: z.ZodString;
|
|
1507
1698
|
to: z.ZodString;
|
|
1508
1699
|
}, "strip", z.ZodTypeAny, {
|
|
1509
|
-
from: string;
|
|
1510
1700
|
to: string;
|
|
1511
|
-
}, {
|
|
1512
1701
|
from: string;
|
|
1702
|
+
}, {
|
|
1513
1703
|
to: string;
|
|
1704
|
+
from: string;
|
|
1514
1705
|
}>;
|
|
1515
1706
|
attendees: z.ZodArray<z.ZodObject<{
|
|
1516
1707
|
name: z.ZodString;
|
|
@@ -1529,15 +1720,15 @@ declare const ManagementReviewFrontmatterSchema: z.ZodObject<{
|
|
|
1529
1720
|
title: string;
|
|
1530
1721
|
review_date: string;
|
|
1531
1722
|
review_period: {
|
|
1532
|
-
from: string;
|
|
1533
1723
|
to: string;
|
|
1724
|
+
from: string;
|
|
1534
1725
|
};
|
|
1535
1726
|
attendees: {
|
|
1536
1727
|
name: string;
|
|
1537
1728
|
role: string;
|
|
1538
1729
|
}[];
|
|
1539
|
-
status?: "draft" | "completed" | "scheduled" | undefined;
|
|
1540
1730
|
type?: "management_review" | undefined;
|
|
1731
|
+
status?: "draft" | "completed" | "scheduled" | undefined;
|
|
1541
1732
|
version?: string | undefined;
|
|
1542
1733
|
data_snapshot_date?: string | undefined;
|
|
1543
1734
|
next_review_date?: string | undefined;
|
|
@@ -1546,43 +1737,29 @@ declare const ManagementReviewFrontmatterSchema: z.ZodObject<{
|
|
|
1546
1737
|
title: string;
|
|
1547
1738
|
review_date: string;
|
|
1548
1739
|
review_period: {
|
|
1549
|
-
from: string;
|
|
1550
1740
|
to: string;
|
|
1741
|
+
from: string;
|
|
1551
1742
|
};
|
|
1552
1743
|
attendees: {
|
|
1553
1744
|
name: string;
|
|
1554
1745
|
role: string;
|
|
1555
1746
|
}[];
|
|
1556
|
-
status?: "draft" | "completed" | "scheduled" | undefined;
|
|
1557
1747
|
type?: "management_review" | undefined;
|
|
1748
|
+
status?: "draft" | "completed" | "scheduled" | undefined;
|
|
1558
1749
|
version?: string | undefined;
|
|
1559
1750
|
data_snapshot_date?: string | undefined;
|
|
1560
1751
|
next_review_date?: string | undefined;
|
|
1561
1752
|
}>;
|
|
1562
1753
|
type ManagementReviewFrontmatter = z.infer<typeof ManagementReviewFrontmatterSchema>;
|
|
1563
1754
|
|
|
1564
|
-
/**
|
|
1565
|
-
* Shared validation schemas
|
|
1566
|
-
*
|
|
1567
|
-
* This file contains only validators and enums used for parsing and validation.
|
|
1568
|
-
* Full entity schemas have been removed per ADR-014 (backend-only validation).
|
|
1569
|
-
*/
|
|
1570
|
-
|
|
1571
|
-
declare const RegulatoryFrameworkSchema: z.ZodEnum<["ISO_13485", "IEC_62304", "FDA_21_CFR_820"]>;
|
|
1572
|
-
declare const SafetyClassSchema: z.ZodEnum<["A", "B", "C"]>;
|
|
1573
|
-
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", "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", "report"]>;
|
|
1574
|
-
declare const DocumentStatusSchema: z.ZodEnum<["draft", "in_review", "approved", "obsolete", "example"]>;
|
|
1575
|
-
declare const LinkTypeSchema: z.ZodEnum<["derives_from", "implements", "verified_by", "mitigates", "parent_of", "related_to", "leads_to", "results_in", "analyzes"]>;
|
|
1576
|
-
declare const AcceptabilityStatusSchema: z.ZodEnum<["acceptable", "review_required", "unacceptable"]>;
|
|
1577
|
-
|
|
1578
1755
|
/**
|
|
1579
1756
|
* Document type constants for QMS and Device bounded contexts.
|
|
1580
1757
|
*
|
|
1581
1758
|
* QMS documents are company-wide quality procedures.
|
|
1582
1759
|
* Device documents are product-specific documentation.
|
|
1583
1760
|
*/
|
|
1584
|
-
declare const QMS_DOCUMENT_TYPES: readonly ["sop", "policy", "work_instruction", "supplier", "
|
|
1585
|
-
declare const DEVICE_DOCUMENT_TYPES: readonly ["user_need", "requirement", "architecture", "detailed_design", "test_protocol", "test_report", "usability_risk", "software_risk", "security_risk", "hazardous_situation", "harm", "haz_soe_software", "haz_soe_security", "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"];
|
|
1761
|
+
declare const QMS_DOCUMENT_TYPES: readonly ["sop", "policy", "work_instruction", "supplier", "audit_schedule", "audit_report", "management_review"];
|
|
1762
|
+
declare const DEVICE_DOCUMENT_TYPES: readonly ["user_need", "requirement", "architecture", "detailed_design", "test_protocol", "test_report", "usability_risk", "software_risk", "security_risk", "hazardous_situation", "harm", "haz_soe_software", "haz_soe_security", "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", "software_test_plan"];
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type QmsDocumentType = (typeof QMS_DOCUMENT_TYPES)[number];
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type DeviceDocumentType = (typeof DEVICE_DOCUMENT_TYPES)[number];
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/**
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@@ -1632,7 +1809,7 @@ declare const REQUIRED_SECTIONS: Partial<Record<DocumentType, string[]>>;
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* all frontmatter schemas added since that script was last maintained.
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*
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* Document types without a dedicated schema (architecture, detailed_design,
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-
* sop, work_instruction, policy, supplier
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1812
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+
* sop, work_instruction, policy, supplier) use only base frontmatter
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1813
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* fields (id, title, status, type, author, reviewers, approvers) and are
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* NOT included here — callers should fall back to a generic base schema.
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*/
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@@ -1641,14 +1818,73 @@ declare const REQUIRED_SECTIONS: Partial<Record<DocumentType, string[]>>;
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* Maps document type strings to their Zod frontmatter validation schema.
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*
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* Document types not listed here (architecture, detailed_design, sop,
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-
* work_instruction, policy, supplier
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1821
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+
* work_instruction, policy, supplier) have no type-specific schema
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* and rely on the generic base frontmatter fields only.
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*/
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-
declare const SCHEMA_MAP: Partial<Record<string, z.
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+
declare const SCHEMA_MAP: Partial<Record<string, z.ZodType>>;
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/**
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* Returns the Zod frontmatter schema for a given document type, or
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* `undefined` if the type uses only base frontmatter fields.
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*/
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-
declare function getSchemaForDocumentType(type: string): z.
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|
+
declare function getSchemaForDocumentType(type: string): z.ZodType | undefined;
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+
|
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+
/**
|
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1832
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+
* Document Structure Validator (pure — no I/O)
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+
*
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+
* Validates markdown documents against PactoSigna's ISO 13485 document format:
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+
* frontmatter schemas, folder placement, ID prefix conventions, and required sections.
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+
*/
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interface StructureError {
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+
code: string;
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+
message: string;
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+
field?: string;
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}
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+
interface StructureWarning {
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+
code: string;
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+
message: string;
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+
}
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|
+
interface ValidationResult {
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+
path: string;
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+
documentId: string | null;
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+
docType: string | null;
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+
errors: StructureError[];
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+
warnings: StructureWarning[];
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+
}
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+
/**
|
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+
* Validate a single markdown document's content against its expected schema.
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+
*
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+
* @param content - Raw file content (including frontmatter)
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+
* @param filePath - Repo-relative path (e.g. 'docs/software/requirements/SRS-001.md')
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+
* @returns Validation result with errors and warnings
|
|
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+
*/
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|
+
declare function validateDocument(content: string, filePath: string): ValidationResult;
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1861
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+
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1862
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+
/**
|
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1863
|
+
* Directory Structure Validator (I/O — uses node:fs)
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+
*
|
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|
+
* Walks a directory tree and validates all markdown documents found within it.
|
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|
+
*/
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|
+
|
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|
+
interface DirectoryValidationResult {
|
|
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|
+
results: ValidationResult[];
|
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|
+
summary: {
|
|
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|
+
total: number;
|
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|
+
passed: number;
|
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|
+
failed: number;
|
|
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|
+
warnings: number;
|
|
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|
+
};
|
|
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|
+
orphanFolders: string[];
|
|
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|
+
strayFiles: string[];
|
|
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|
+
}
|
|
1879
|
+
/**
|
|
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|
+
* Validate all documents in a directory tree.
|
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|
+
*
|
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|
+
* @param dirPath - Absolute or relative path to the docs root
|
|
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|
+
* @param options - Optional exclusion list (path prefix matching)
|
|
1884
|
+
* @returns Aggregated results with summary and directory-level checks
|
|
1885
|
+
*/
|
|
1886
|
+
declare function validateDirectory(dirPath: string, options?: {
|
|
1887
|
+
exclude?: string[];
|
|
1888
|
+
}): DirectoryValidationResult;
|
|
1653
1889
|
|
|
1654
|
-
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, DocumentStatusSchema, DocumentTypeSchema, type HarmFrontmatter, HarmFrontmatterSchema, 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 SoupRegisterFrontmatter, SoupRegisterFrontmatterSchema, 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, getEffectiveRetentionYears, getSchemaForDocumentType, isChangeDocumentType, isDeviceDocumentType, isQmsDocumentType, isWithinRetentionPeriod };
|
|
1890
|
+
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 };
|