@connexum/ai-governance 1.0.0-beta.11

package/dist/packs/fda-21-cfr-820.js

@@ -0,0 +1,609 @@
+"use strict";
+/**
+ * FDA 21 CFR Part 820 — Quality System Regulation (QSR) Compliance Pack
+ *
+ * Quality System Regulation for finished medical device manufacturers
+ * selling in the United States. Effective since 1996; superseded the
+ * 1978 GMP (Good Manufacturing Practices) requirements.
+ *
+ * Standards referenced:
+ *   - 21 CFR Part 820 (QSR) — subparts B through O
+ *   - 21 CFR Part 820 Subpart B: Management Responsibility (§ 820.20–820.25)
+ *   - 21 CFR Part 820 Subpart C: Design Controls (§ 820.30)
+ *   - 21 CFR Part 820 Subpart D: Document Controls (§ 820.40)
+ *   - 21 CFR Part 820 Subpart E: Purchasing Controls (§ 820.50)
+ *   - 21 CFR Part 820 Subpart F: Identification & Traceability (§ 820.60–820.65)
+ *   - 21 CFR Part 820 Subpart G: Production & Process Controls (§ 820.70–820.75)
+ *   - 21 CFR Part 820 Subpart J: Corrective & Preventive Action (CAPA) (§ 820.100)
+ *   - 21 CFR Part 820 Subpart L: Handling/Storage/Distribution/Installation (§ 820.140–820.170)
+ *   - 21 CFR Part 820 Subpart M: Records (§ 820.180–820.198)
+ *   - 21 CFR Part 820 Subpart N: Servicing (§ 820.200)
+ *   - 21 CFR Part 820 Subpart O: Statistical Techniques (§ 820.250)
+ *   - 21 CFR Part 803 (Medical Device Reporting — MDR): 30-day / 5-day clocks
+ *   - QMSR (FDA Quality Management System Regulation, Feb 2024): harmonises
+ *     21 CFR Part 820 with ISO 13485:2016. Compliance deadline: 6 Feb 2026.
+ *     Legacy QSR systems still valid under transition; this pack supports BOTH.
+ *
+ * Key data records:
+ *   DHF  — Design History File (§ 820.30(j))
+ *   DMR  — Device Master Record (§ 820.181)
+ *   DHR  — Device History Record (§ 820.184)
+ *   CAPA — Corrective and Preventive Action record (§ 820.100)
+ *
+ * Retention: device lifetime + 2 years per § 820.180(b). This pack uses
+ * 10,950 days (≈ 30 years) as a conservative representative lifetime + buffer,
+ * consistent with FDA industry practice for long-lifetime implantable devices.
+ * Implementers MUST configure actual device lifetime for their product class.
+ *
+ * @connexum/ai-governance
+ */
+Object.defineProperty(exports, "__esModule", { value: true });
+exports.FDA_21_CFR_820_PACK = exports.FDA_21_CFR_820_CATEGORY_CLASSIFIERS = void 0;
+const _base_classifiers_1 = require("./_base-classifiers");
+// ---------------------------------------------------------------------------
+// Category classifiers
+// ---------------------------------------------------------------------------
+/**
+ * FDA 21 CFR Part 820 / QSR category classifiers.
+ *
+ * Records are classified by their regulatory role under the QSR.
+ * Unauthorised modification of controlled records is BLOCKED.
+ * Regulated quality records carry mandatory audit trails.
+ */
+exports.FDA_21_CFR_820_CATEGORY_CLASSIFIERS = {
+    /**
+     * DESIGN_HISTORY_FILE — § 820.30(j)
+     * Contains the compiled documentation for a finished device design.
+     * Unauthorised modifications are a BLOCK (records must be authorised,
+     * dated, and reviewed per § 820.40 document-control procedures).
+     */
+    DESIGN_HISTORY_FILE: {
+        references: ['21 CFR 820.30(j) -- DHF must demonstrate that the design was developed in accordance with the approved design plan'],
+        classifier: (input) => {
+            if (/\b(?:design\s+history\s+file|DHF)\b/i.test(input))
+                return true;
+            if (/\bDHF[-_\s]+(?:record|entry|update|modification|draft)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    /**
+     * DEVICE_MASTER_RECORD — § 820.181
+     * Contains the procedures and specifications for a finished device.
+     * Must be maintained to ensure reproducibility.
+     */
+    DEVICE_MASTER_RECORD: {
+        references: ['21 CFR 820.181 -- DMR: procedures and specifications needed to manufacture a finished device'],
+        classifier: (input) => {
+            if (/\b(?:device\s+master\s+record|DMR)\b/i.test(input))
+                return true;
+            if (/\bDMR[-_\s]+(?:record|spec|specification|update|modification)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    /**
+     * DEVICE_HISTORY_RECORD — § 820.184
+     * Contains the production history for each manufactured unit or lot.
+     * Evidence that the device was manufactured according to the DMR.
+     */
+    DEVICE_HISTORY_RECORD: {
+        references: ['21 CFR 820.184 -- DHR: production history demonstrating device manufactured in conformance with DMR'],
+        classifier: (input) => {
+            if (/\b(?:device\s+history\s+record|DHR)\b/i.test(input))
+                return true;
+            if (/\bDHR[-_\s]+(?:record|lot|batch|update|modification)\b/i.test(input))
+                return true;
+            if (/\b(?:production\s+history|manufacturing\s+lot\s+record)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    /**
+     * CORRECTIVE_ACTION — § 820.100(a)
+     * CAPA initiation record. AI agents must route CAPA initiation for human
+     * review — this is a quality-management gateway event.
+     */
+    CORRECTIVE_ACTION: {
+        references: ['21 CFR 820.100(a) -- CAPA: identify and implement corrective action to prevent recurrence'],
+        classifier: (input) => {
+            if (/\b(?:corrective\s+action|CAPA\s+initiation|CAPA[-_\s]+record)\b/i.test(input))
+                return true;
+            if (/\b(?:root\s+cause\s+analysis|nonconformance\s+investigation|deviation\s+report)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    /**
+     * PREVENTIVE_ACTION — § 820.100(a)(7)
+     * Preventive action record — distinct from corrective action; addresses
+     * potential (not yet observed) quality failures.
+     */
+    PREVENTIVE_ACTION: {
+        references: ['21 CFR 820.100(a)(7) -- preventive action: identify action to prevent occurrence of nonconformities'],
+        classifier: (input) => {
+            if (/\b(?:preventive\s+action|preventative\s+action)\b/i.test(input))
+                return true;
+            if (/\b(?:risk\s+assessment\s+action|quality\s+improvement\s+action)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    /**
+     * MANAGEMENT_REVIEW_RECORD — § 820.20(c)
+     * Records of management reviews of the quality system.
+     * Must include dates, attendees, results, and actions.
+     */
+    MANAGEMENT_REVIEW_RECORD: {
+        references: ['21 CFR 820.20(c) -- management review: periodic review of quality system suitability and effectiveness'],
+        classifier: (input) => {
+            if (/\b(?:management\s+review|QMS\s+review\s+record)\b/i.test(input))
+                return true;
+            if (/\b(?:executive\s+quality\s+review|annual\s+quality\s+review)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    /**
+     * DESIGN_INPUT — § 820.30(c)
+     * Physical and performance requirements for the device.
+     */
+    DESIGN_INPUT: {
+        references: ['21 CFR 820.30(c) -- design input: physical and performance requirements for the device'],
+        classifier: (input) => {
+            if (/\b(?:design\s+input|design\s+requirement|device\s+specification\s+requirement)\b/i.test(input))
+                return true;
+            if (/\b(?:user\s+need\s+specification|intended\s+use\s+requirement)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    /**
+     * DESIGN_OUTPUT — § 820.30(d)
+     * Results of a design phase; must be reviewed and approved.
+     */
+    DESIGN_OUTPUT: {
+        references: ['21 CFR 820.30(d) -- design output: results that meet design input requirements'],
+        classifier: (input) => {
+            if (/\b(?:design\s+output|design\s+specification|device\s+design\s+output)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    /**
+     * DESIGN_VERIFICATION — § 820.30(f)
+     * Confirmation that design output meets design input requirements.
+     */
+    DESIGN_VERIFICATION: {
+        references: ['21 CFR 820.30(f) -- design verification: confirm design output meets design input requirements'],
+        classifier: (input) => {
+            if (/\b(?:design\s+verification|verification\s+protocol|verification\s+report)\b/i.test(input))
+                return true;
+            if (/\b(?:OQ|IQ|PQ)\s+(?:protocol|report|record)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    /**
+     * DESIGN_VALIDATION — § 820.30(g)
+     * Ensures devices conform to defined user needs and intended uses.
+     * Must include risk analysis and clinical or simulated-use testing.
+     */
+    DESIGN_VALIDATION: {
+        references: ['21 CFR 820.30(g) -- design validation: confirm device conforms to defined user needs and intended uses'],
+        classifier: (input) => {
+            if (/\b(?:design\s+validation|clinical\s+validation\s+record|simulated\s+use\s+test)\b/i.test(input))
+                return true;
+            if (/\b(?:usability\s+validation|human\s+factors\s+validation)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    /**
+     * DESIGN_CHANGE — § 820.30(i)
+     * Design changes must be verified, validated, reviewed, and approved
+     * before implementation. AI agents must BLOCK unapproved design changes.
+     */
+    DESIGN_CHANGE: {
+        references: ['21 CFR 820.30(i) -- design changes: verify, validate, review, and approve before implementation'],
+        classifier: (input) => {
+            if (/\b(?:design\s+change|design\s+change\s+request|DCR|ECO|engineering\s+change\s+order)\b/i.test(input))
+                return true;
+            if (/\b(?:design\s+modification|design\s+amendment)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    /**
+     * NONCONFORMING_PRODUCT — § 820.90
+     * Procedures for controlling product that does not conform to specifications.
+     */
+    NONCONFORMING_PRODUCT: {
+        references: ['21 CFR 820.90 -- nonconforming product: control procedures for non-specification product'],
+        classifier: (input) => {
+            if (/\b(?:nonconform(?:ing|ance)|non-conform(?:ing|ance)|NCR)\b/i.test(input))
+                return true;
+            if (/\b(?:rejected\s+(?:product|device|component)|disposition\s+record|MRB\s+record)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    /**
+     * COMPLAINT_RECORD — § 820.198
+     * Every complaint received must be evaluated and, if it concerns a
+     * malfunction, injury, or death, an MDR may be required.
+     */
+    COMPLAINT_RECORD: {
+        references: ['21 CFR 820.198 -- complaint files: evaluate all complaints; investigate MDR-reportable events'],
+        classifier: (input) => {
+            if (/\b(?:complaint\s+(?:file|record|report)|customer\s+complaint)\b/i.test(input))
+                return true;
+            if (/\b(?:adverse\s+event\s+complaint|product\s+complaint)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    /**
+     * MDR_REPORT — § 820.198 + 21 CFR Part 803
+     * Medical Device Report — mandatory adverse-event report to FDA.
+     * 30-day deadline for death/serious injury; 5-day for unplanned
+     * corrective actions to prevent substantial risk (§ 803.53).
+     * AI agents must BLOCK delays beyond the 5-day threshold.
+     */
+    MDR_REPORT: {
+        references: [
+            '21 CFR 820.198 -- complaint: determine if MDR filing required',
+            '21 CFR Part 803 -- MDR: report to FDA within 30 days (death/serious injury) or 5 days (corrective action)',
+        ],
+        classifier: (input) => {
+            if (/\b(?:medical\s+device\s+report|MDR\s+(?:filing|submission|report))\b/i.test(input))
+                return true;
+            if (/\b(?:adverse\s+event\s+report|MAUDE\s+report|MDR\s+30.?day|MDR\s+5.?day)\b/i.test(input))
+                return true;
+            if (/\b(?:serious\s+injury\s+report|death\s+report\s+device|device\s+malfunction\s+report)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    /**
+     * PHI — shared classifier (§ 820 QMSR may intersect HIPAA when device
+     * processes patient health information).
+     */
+    PHI: {
+        references: ['21 CFR 820 QMSR -- intersection with HIPAA when device or AI system processes patient data'],
+        classifier: (input) => {
+            return (0, _base_classifiers_1.sharedPhiClassifier)(input);
+        },
+    },
+    /**
+     * CREDENTIALS — access controls per § 820.20 + § 820.40
+     */
+    CREDENTIALS: {
+        references: ['21 CFR 820.20 / 820.40 -- access controls; document control authorisation'],
+        classifier: (input) => {
+            if (/\b(?:api[_-]?key|apikey)\s*[=:]\s*["']?[A-Za-z0-9_\-\/+]{16,}["']?/i.test(input))
+                return true;
+            if (/\bpassword\s*[=:]\s*["']?[A-Za-z0-9!@#$%^&*_\-]{8,}["']?/i.test(input))
+                return true;
+            if (/-----BEGIN\s+(?:RSA\s+)?PRIVATE\s+KEY-----/.test(input))
+                return true;
+            return false;
+        },
+    },
+};
+// ---------------------------------------------------------------------------
+// Pack definition
+// ---------------------------------------------------------------------------
+exports.FDA_21_CFR_820_PACK = {
+    categoryClassifiers: exports.FDA_21_CFR_820_CATEGORY_CLASSIFIERS,
+    /** PHI in a device context is subject-keyed to the patient record. */
+    subjectKeyedCategories: ['PHI', 'COMPLAINT_RECORD', 'MDR_REPORT'],
+    id: 'fda-21-cfr-820',
+    name: 'FDA 21 CFR Part 820 Quality System Regulation (QSR)',
+    version: '1.0.0',
+    description: 'FDA Quality System Regulation (21 CFR Part 820) for finished medical device manufacturers. ' +
+        'Covers design controls (DHF/DMR/DHR), CAPA, document controls, complaint files, and MDR ' +
+        'reporting (30-day / 5-day clocks). Supports both legacy QSR and the Feb 2026 QMSR ' +
+        'transition (harmonised with ISO 13485:2016). Retention: device lifetime + 2 years (§ 820.180).',
+    authority: 'US Food and Drug Administration (FDA) — Center for Devices and Radiological Health (CDRH)',
+    industries: [
+        'medical-devices',
+        'digital-health',
+        'diagnostic-devices',
+        'therapeutic-devices',
+        'combination-products',
+        'in-vitro-diagnostics',
+        'implantable-devices',
+        'medical-device-manufacturing',
+        'contract-manufacturing-device',
+    ],
+    requiredModules: [
+        {
+            name: 'governance-runtime',
+            required: true,
+            reason: 'QSR design-control gate; CAPA workflow management; management review scheduling (§ 820.20 / § 820.30 / § 820.100)',
+            reference: '21 CFR 820.20, 820.30, 820.100',
+        },
+        {
+            name: 'audit-integrity',
+            required: true,
+            reason: 'DHF / DMR / DHR tamper-evident audit trail; § 820.180 records integrity; QMSR audit-chain alignment',
+            reference: '21 CFR 820.180 -- records; 21 CFR 820.30(j) DHF; 21 CFR 820.181 DMR; 21 CFR 820.184 DHR',
+        },
+        {
+            name: 'data-classifier',
+            required: true,
+            reason: 'QSR data-element classification (DHF / DMR / DHR / CAPA / MDR / complaint); PHI detection at HIPAA intersection',
+            reference: '21 CFR 820.30, 820.100, 820.180, 820.198; HIPAA when PHI processed',
+        },
+        {
+            name: 'approval-queue',
+            required: true,
+            reason: 'Human review gate for CAPA initiation; design-change T2 approval; MDR filing authorisation; document-control sign-off (§ 820.40)',
+            reference: '21 CFR 820.30(i) design change; 21 CFR 820.40 document control; 21 CFR 820.100 CAPA',
+        },
+        {
+            name: 'event-bus',
+            required: true,
+            reason: 'MDR 30-day and 5-day reporting clocks (21 CFR Part 803); CAPA due-date enforcement; complaint-file SLA alerts',
+            reference: '21 CFR Part 803 MDR; 21 CFR 820.100 CAPA; 21 CFR 820.198 complaints',
+        },
+        {
+            name: 'attestation-manager',
+            required: true,
+            reason: 'Design verification / validation attestations (IQ/OQ/PQ); management review attestation; QMSR ISO 13485 alignment evidence',
+            reference: '21 CFR 820.30(f)(g) verification and validation; 21 CFR 820.20(c) management review; QMSR 2024',
+        },
+        {
+            name: 'supply-chain',
+            required: true,
+            reason: 'Purchasing controls (§ 820.50): supplier qualification, approved supplier list, incoming acceptance; component traceability (§ 820.60)',
+            reference: '21 CFR 820.50 purchasing controls; 21 CFR 820.60 identification; 21 CFR 820.65 traceability',
+        },
+        {
+            name: 'anomaly-detector',
+            required: true,
+            reason: 'Production process monitoring for out-of-control conditions (§ 820.70); complaint trend analysis for MDR signal detection',
+            reference: '21 CFR 820.70 production controls; 21 CFR 820.198 complaint files',
+        },
+        {
+            name: 'transparency-injector',
+            required: true,
+            reason: 'Labelling and intended-use disclosure (§ 820.120); design-change disclosure to stakeholders',
+            reference: '21 CFR 820.120 device labelling; 21 CFR 820.30(i) design change notification',
+        },
+        {
+            name: 'session-persistence',
+            required: true,
+            reason: 'Continuous design-history and CAPA continuity across sessions; § 820.180 record availability across device lifetime',
+            reference: '21 CFR 820.180 records -- availability throughout device lifetime + 2 years',
+        },
+    ],
+    moduleConfig: {
+        'governance-runtime': {
+            qaSystemValidationRequired: true,
+            designControlWorkflowRequired: true,
+            capaWorkflowRequired: true,
+            managementReviewSchedulingRequired: true,
+            documentControlAuthorizationRequired: true,
+        },
+        'audit-integrity': {
+            dhfAuditChainRequired: true,
+            dmrAuditChainRequired: true,
+            dhrAuditChainRequired: true,
+            capaAuditTrailRequired: true,
+            qmsrAlignmentRequired: true,
+        },
+        'approval-queue': {
+            capaInitiationReviewRequired: true,
+            designChangeT2ReviewRequired: true,
+            mdrFilingAuthorizationRequired: true,
+            documentControlSignOffRequired: true,
+            designOutputReviewRequired: true,
+        },
+        'event-bus': {
+            mdrThirtyDayClockActive: true,
+            mdrFiveDayCorrectiveActionClockActive: true,
+            capaClosureDueDateEnforcementActive: true,
+            complaintFileSlaAlertsActive: true,
+        },
+        'attestation-manager': {
+            designVerificationAttestationRequired: true,
+            designValidationAttestationRequired: true,
+            managementReviewAttestationRequired: true,
+            qmsrIso13485AlignmentEvidenceRequired: true,
+        },
+        'supply-chain': {
+            approvedSupplierListRequired: true,
+            supplierQualificationRequired: true,
+            incomingAcceptanceRecordRequired: true,
+            componentTraceabilityRequired: true,
+        },
+        'anomaly-detector': {
+            productionProcessMonitoringActive: true,
+            complaintTrendAnalysisActive: true,
+            mdrSignalDetectionActive: true,
+        },
+    },
+    providerPolicy: {
+        blockedProviders: ['deepseek', 'baidu', 'alibaba'],
+        requiredCapabilities: ['FDA-QSR-READY', 'HIPAA-COMPLIANT'],
+        blockReasons: {
+            deepseek: 'PRC jurisdiction; cannot support FDA QSR supplier oversight, DHF/DMR/DHR controls, or patient-data protection.',
+            baidu: 'PRC jurisdiction; clinical and quality-system data protection risk under QSR.',
+            alibaba: 'PRC jurisdiction; quality-record and patient-data protection risk under QSR.',
+        },
+    },
+    dataPolicy: {
+        scanCategories: [
+            'DESIGN_HISTORY_FILE',
+            'DEVICE_MASTER_RECORD',
+            'DEVICE_HISTORY_RECORD',
+            'CORRECTIVE_ACTION',
+            'PREVENTIVE_ACTION',
+            'MANAGEMENT_REVIEW_RECORD',
+            'DESIGN_INPUT',
+            'DESIGN_OUTPUT',
+            'DESIGN_VERIFICATION',
+            'DESIGN_VALIDATION',
+            'DESIGN_CHANGE',
+            'NONCONFORMING_PRODUCT',
+            'COMPLAINT_RECORD',
+            'MDR_REPORT',
+            'PHI',
+            'CREDENTIALS',
+        ],
+        categoryActions: {
+            // Core QSR controlled records — unauthorised modifications are BLOCKED
+            DESIGN_HISTORY_FILE: 'BLOCK',
+            DEVICE_MASTER_RECORD: 'BLOCK',
+            DEVICE_HISTORY_RECORD: 'BLOCK',
+            // CAPA initiation goes to human REVIEW (quality gateway event)
+            CORRECTIVE_ACTION: 'REVIEW',
+            PREVENTIVE_ACTION: 'REVIEW',
+            // Management review records — log for audit trail
+            MANAGEMENT_REVIEW_RECORD: 'LOG',
+            // Design control records — LOG for evidence capture; DESIGN_CHANGE BLOCKED (§ 820.30(i))
+            DESIGN_INPUT: 'LOG',
+            DESIGN_OUTPUT: 'LOG',
+            DESIGN_VERIFICATION: 'LOG',
+            DESIGN_VALIDATION: 'LOG',
+            DESIGN_CHANGE: 'BLOCK',
+            // Quality records — REVIEW for nonconformances; BLOCK for complaint without MDR evaluation
+            NONCONFORMING_PRODUCT: 'REVIEW',
+            COMPLAINT_RECORD: 'REVIEW',
+            // MDR — BLOCK on late-filing detection (> 5 days for corrective-action reports)
+            MDR_REPORT: 'BLOCK',
+            PHI: 'BLOCK',
+            CREDENTIALS: 'BLOCK',
+        },
+        encryptionRequired: true,
+        encryptionStandard: 'AES-256-GCM',
+        minimumClassification: 'RESTRICTED',
+    },
+    retentionPolicy: {
+        sovereignty: ['US'],
+        // § 820.180(b): records must be retained for the lifetime of the device
+        // but no less than 2 years from the date of release for commercial distribution.
+        // 10,950 days ≈ 30 years; implementers MUST adjust for actual device class.
+        auditLogRetentionDays: 10950,
+        sessionRetentionDays: 730,
+        incidentRetentionDays: 10950,
+        reference: '21 CFR 820.180(b) -- records retained for device lifetime + 2 years (minimum 2 years from commercial release); 10,950 days used as conservative long-lifetime implantable device representative',
+    },
+    incidentPolicy: {
+        // MDR 5-day clock for unplanned corrective actions (21 CFR 803.53)
+        notificationDeadlineHours: 120, // 5 days × 24 hours
+        reference: '21 CFR Part 803 MDR: 30 days for death/serious injury (§ 803.50); 5 days for unplanned corrective action to prevent substantial risk (§ 803.53). Filed via FDA MAUDE system.',
+        requiredRecipients: ['fda-maude', 'quality-leadership', 'regulatory-affairs', 'risk-management', 'medical-affairs'],
+        formalNotificationRequired: true,
+    },
+    validators: [
+        {
+            id: 'fda-820-dhf-controls',
+            description: 'Design History File (DHF) maintained per § 820.30(j) with authorised, dated entries',
+            reference: '21 CFR 820.30(j)',
+            check: 'fda_820_dhf_controls_active',
+            failSeverity: 'CRITICAL',
+        },
+        {
+            id: 'fda-820-dmr-controls',
+            description: 'Device Master Record (DMR) maintained per § 820.181 — procedures and specifications current',
+            reference: '21 CFR 820.181',
+            check: 'fda_820_dmr_controls_active',
+            failSeverity: 'CRITICAL',
+        },
+        {
+            id: 'fda-820-dhr-controls',
+            description: 'Device History Record (DHR) maintained per § 820.184 — production history complete for each lot',
+            reference: '21 CFR 820.184',
+            check: 'fda_820_dhr_controls_active',
+            failSeverity: 'CRITICAL',
+        },
+        {
+            id: 'fda-820-capa',
+            description: 'CAPA system active: corrective and preventive actions routed for human review (§ 820.100)',
+            reference: '21 CFR 820.100',
+            check: 'fda_820_capa_active',
+            failSeverity: 'CRITICAL',
+        },
+        {
+            id: 'fda-820-mdr-clock',
+            description: 'MDR 30-day / 5-day reporting clocks configured and enforced (21 CFR Part 803)',
+            reference: '21 CFR Part 803 (MDR)',
+            check: 'fda_820_mdr_clock_active',
+            failSeverity: 'CRITICAL',
+        },
+        {
+            id: 'fda-820-design-change-review',
+            description: 'Design changes gated by T2 human review before implementation (§ 820.30(i))',
+            reference: '21 CFR 820.30(i)',
+            check: 'fda_820_design_change_review_active',
+            failSeverity: 'CRITICAL',
+        },
+        {
+            id: 'fda-820-document-control',
+            description: 'Document control procedures in place: authorisation, dating, and change control (§ 820.40)',
+            reference: '21 CFR 820.40',
+            check: 'fda_820_document_control_active',
+            failSeverity: 'HIGH',
+        },
+        {
+            id: 'fda-820-management-review',
+            description: 'Management review scheduled and attested at defined intervals (§ 820.20(c))',
+            reference: '21 CFR 820.20(c)',
+            check: 'fda_820_management_review_active',
+            failSeverity: 'HIGH',
+        },
+        {
+            id: 'fda-820-design-verification-validation',
+            description: 'Design verification (§ 820.30(f)) and validation (§ 820.30(g)) attestations on file',
+            reference: '21 CFR 820.30(f)(g)',
+            check: 'fda_820_design_vv_active',
+            failSeverity: 'CRITICAL',
+        },
+        {
+            id: 'fda-820-purchasing-controls',
+            description: 'Purchasing controls active: approved supplier list, supplier qualification, incoming acceptance (§ 820.50)',
+            reference: '21 CFR 820.50',
+            check: 'fda_820_purchasing_controls_active',
+            failSeverity: 'HIGH',
+        },
+        {
+            id: 'fda-820-complaint-files',
+            description: 'Complaint file procedures active: evaluation, investigation, MDR determination (§ 820.198)',
+            reference: '21 CFR 820.198',
+            check: 'fda_820_complaint_files_active',
+            failSeverity: 'HIGH',
+        },
+        {
+            id: 'fda-820-nonconforming-product',
+            description: 'Nonconforming product control procedures active: identification, disposition, MRB (§ 820.90)',
+            reference: '21 CFR 820.90',
+            check: 'fda_820_nonconforming_product_active',
+            failSeverity: 'HIGH',
+        },
+        {
+            id: 'fda-820-production-controls',
+            description: 'Production and process controls active: monitoring, process validation records (§ 820.70)',
+            reference: '21 CFR 820.70',
+            check: 'fda_820_production_controls_active',
+            failSeverity: 'HIGH',
+        },
+        {
+            id: 'fda-820-traceability',
+            description: 'Identification and traceability procedures active for all device components and lots (§ 820.60–820.65)',
+            reference: '21 CFR 820.60 / 820.65',
+            check: 'fda_820_traceability_active',
+            failSeverity: 'HIGH',
+        },
+        {
+            id: 'fda-820-records-retention',
+            description: 'Records retained for device lifetime + 2 years minimum; audit log configured >= 730 days (§ 820.180)',
+            reference: '21 CFR 820.180(b)',
+            check: 'fda_820_records_retention_active',
+            failSeverity: 'CRITICAL',
+        },
+    ],
+};
+//# sourceMappingURL=fda-21-cfr-820.js.map

package/dist/packs/fda-21-cfr-820.js.map

@@ -0,0 +1 @@
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