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Compliance Documentation Index

Last Updated: 2025-07-15
Compliance Mode: Medical Device (21 CFR Part 11, ISO 13485, ISO 14971, GAMP 5)
Status: Implementation Ready

🏥 Medical CSV Compliance System​

Primary Documentation​

DocumentPurposeLocationStatus
REQ-020Medical CSV Compliance RequirementFile moved or archived - see requirements/renaissance/ for current requirements⚠️ Update needed
Implementation Roadmap3-phase implementation plandocs/MEDICAL_CSV_IMPLEMENTATION_ROADMAP.md✅ Complete
ConfigurationMedical compliance JSON configsupernal-code.config.json✅ Complete
TestsComprehensive compliance testingtests/requirements/req-020/✅ 17/17 Passing

Regulatory Standards Coverage​

21 CFR Part 11 - Electronic Records and Electronic Signatures​

  • Requirement: REQ-020 Sections 1-2
  • Configuration: [compliance.audit] and [compliance.electronic_signatures]
  • Implementation: Phase 1-2 (Weeks 1-4)
  • Key Features:
    • Immutable audit trails with 25-year retention
    • ALCOA+ data integrity (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available)
    • Electronic signatures with multi-factor authentication
    • Tamper-evident storage with cryptographic verification

ISO 13485 - Medical Device Quality Management​

  • Requirement: REQ-020 Section 3
  • Configuration: [compliance.validation] and [compliance.change_control]
  • Implementation: Phase 2-3 (Weeks 3-6)
  • Key Features:
    • Quality management system integration
    • Document control procedures
    • Risk management integration
    • Corrective and preventive action (CAPA) processes

ISO 14971 - Risk Management for Medical Devices​

  • Requirement: REQ-020 Section 3
  • Configuration: [compliance.risk_management]
  • Implementation: Phase 3 (Weeks 5-6)
  • Key Features:
    • 5x5 risk matrix (severity × probability)
    • Risk control measures tracking
    • Residual risk evaluation
    • Post-market surveillance integration

GAMP 5 - Good Automated Manufacturing Practice​

  • Requirement: REQ-020 Section 5
  • Configuration: [compliance.validation]
  • Implementation: Phase 5 (Weeks 9-10)
  • Key Features:
    • Risk-based validation approach
    • V-model development lifecycle
    • Installation/Operational/Performance Qualification (IQ/OQ/PQ)
    • Category-based validation protocols

📁 File and Component Index​

Configuration Files​

Primary Configuration​

  • File: supernal-code.config.json
  • Sections: Medical CSV Compliance configuration
  • Key Configurations:
    • [compliance] - Master compliance settings
    • [compliance.audit] - Audit trail configuration
    • [compliance.electronic_signatures] - E-signature settings
    • [compliance.risk_management] - Risk assessment parameters
    • [compliance.access_control] - User access and roles
    • [compliance.reporting] - Regulatory reporting settings

Environment Variables​

  • File: .env (local) or .cursor/mcp.json (MCP integration)
  • Required: Only API keys for AI providers
  • Security: All compliance settings in JSON for auditability

Requirements Management​

Core Requirement​

  • File: Requirements have been reorganized - see requirements/renaissance/ for updated structure
  • Status: Requirements system under active development
  • REQ-003: NPM Package Foundation - Integration platform
  • REQ-011: Git System Enhancement - Version control compliance
  • REQ-019: Rule Tracking System - Compliance rule management

Testing and Validation​

Test Suite​

  • Location: tests/requirements/req-020/req-020.e2e.test.js
  • Coverage: 17 test scenarios covering all regulatory standards
  • Test Categories:
    • Medical Compliance Configuration (4 tests)
    • Requirements Validation (2 tests)
    • Implementation Readiness (3 tests)
    • Regulatory Standards Coverage (4 tests)
    • Success Metrics (2 tests)
    • Integration with Existing System (2 tests)

Validation Protocols (To Be Implemented)​

  • IQ Protocol: Installation Qualification
  • OQ Protocol: Operational Qualification
  • PQ Protocol: Performance Qualification
  • Traceability Matrix: Requirements ↔ Tests ↔ Code

Audit and Logging​

Audit Trail System (To Be Implemented)​

  • Storage: .supernal-code/audit-trail.json (development)
  • Production: Immutable database with encryption
  • Events Tracked:
    • Requirement lifecycle (create, modify, approve, delete)
    • Test execution and results
    • Risk assessments and updates
    • Change control workflow
    • User access and privilege changes

Risk Management (To Be Implemented)​

  • Risk Files: supernal-coding/risks/risk-*.yaml
  • Risk Matrix: 5x5 severity × probability
  • Integration: Linked to requirements via riskId field

Change Control​

Git Integration​

  • Pre-commit Hooks: Medical compliance validation
  • Commit Format: REQ-XXX: <change> Justification: <reason>
  • Branch Protection: Automated validation before merge
  • Audit Integration: All git operations logged

Change Control Process (To Be Implemented)​

  • Change Requests: Formal change request workflow
  • Impact Assessment: Automated downstream impact analysis
  • Approval Matrix: Risk-based approval requirements
  • Implementation Tracking: Complete change lifecycle management

🚀 Implementation Status​

Phase 1: Immediate Foundation (✅ Ready to Start)​

  • Timeline: Weeks 1-2
  • Status: Design complete, ready for implementation
  • Key Deliverables:
    • Enhanced YAML frontmatter with compliance fields
    • Basic audit trail system
    • Risk assessment integration
    • Enhanced git workflow with compliance hooks

Phase 2: Core Compliance Systems (📋 Design Complete)​

  • Timeline: Weeks 3-6
  • Status: Architecture defined, awaiting Phase 1 completion
  • Key Deliverables:
    • Electronic signature system
    • Formal change control process
    • Automated traceability matrix generation

Phase 3: Advanced Validation (📋 Planned)​

  • Timeline: Weeks 7-10
  • Status: Requirements documented, awaiting earlier phases
  • Key Deliverables:
    • Full GAMP 5 validation framework
    • IQ/OQ/PQ protocol generation
    • Risk-based testing automation
    • Regulatory reporting capability

📊 Compliance Metrics and KPIs​

Current Metrics​

  • Requirements with Compliance Fields: 1/17 (REQ-020 only)
  • Test Coverage: 17/17 tests passing for medical compliance
  • Configuration Completeness: 100% medical compliance sections configured
  • Documentation Coverage: 100% regulatory standards documented

Target Metrics (End of Implementation)​

  • Audit Trail Coverage: 100% of regulated activities
  • Data Integrity Violations: 0 (ALCOA+ compliant)
  • Bidirectional Traceability: 100% (requirements ↔ risks ↔ tests ↔ code)
  • Electronic Signature Success Rate: 100%
  • Regulatory Submission Time: Less than 2 hours (automated)
  • Audit Preparation Time: 50% reduction from manual processes

🔗 Integration Points​

Existing System Leverage​

  • YAML Frontmatter: Extended with compliance fields
  • Git Workflow: Enhanced with regulatory controls
  • Testing Framework: Expanded for validation protocols
  • TOML Configuration: Medical compliance sections added
  • Requirements Management: Core platform for compliance

External System Integration (Future)​

  • Quality Management Systems (QMS): Document control integration
  • Document Management Systems (DMS): Centralized document storage
  • Risk Management Systems: Enterprise risk management integration
  • Training Management Systems: Compliance training tracking

📋 Quick Reference​

Starting Medical Compliance Implementation​

  1. Review Requirements:

    cat supernal-coding/requirements/infrastructure/req-020-medical-csv-compliance-system.md

  2. Check Configuration:

    node -e "const { getConfig } = require('./scripts/config-loader'); console.log(getConfig('.').get('compliance.enabled'));"

  3. Run Tests:

    npx jest tests/requirements/req-020/req-020.e2e.test.js

  4. Start Phase 1:

    # Follow MEDICAL_CSV_IMPLEMENTATION_ROADMAP.md Phase 1 steps
    cat docs/MEDICAL_CSV_IMPLEMENTATION_ROADMAP.md

Compliance Checklist for New Requirements​

Add these fields to requirement YAML frontmatter:

riskLevel: [Low|Medium|High|Critical]
complianceStandards: ['21-CFR-Part-11', 'ISO-13485', 'ISO-14971', 'GAMP-5']
safetyRelated: [true|false]
riskId: RISK-XXX
validationRequired: [true|false]
changeControlLevel: [minor|major|critical]
signatureRequired: [true|false]

Emergency Compliance Support​

  • Primary Contact: Quality Assurance Lead
  • Regulatory Consultant: [To be assigned]
  • FDA Liaison: [To be assigned]
  • Audit Support: Complete documentation package available in 2 hours

This compliance system transforms your requirements management into a medical device regulatory-ready platform while maintaining development velocity and workflow efficiency.