Skip to main content

Track D: Compliance & Security

Priority: MEDIUM-HIGH — Parallel with Track C Agent: security-specialist, compliance-framework-specialist Sprint Range: S3-S6

Status Summary​

Progress: 100% (33/33 tasks)

SectionTitleStatusTasks
D.1Critical Gap Closure (Crypto/Signatures)Complete4/4
D.2FDA 21 CFR Part 11 ValidationComplete5/5
D.3HIPAA Security ControlsComplete4/4
D.4SOC 2 Compliance ImplementationComplete4/4
D.5Audit Trail & Evidence PackageComplete8/8
D.6Multi-Tenancy & Tenant LifecycleComplete4/4
D.7Validation Execution & ManagementComplete4/4

D.1: Critical Gap Closure (Crypto/Signatures)​

Sprint: S3 | Priority: P0 | Depends On: None Goal: Close cryptographic foundation gaps identified in compliance analysis Reference: docs/compliance/58-gap-analysis-framework.md

  • D.1.1: Define cryptographic algorithm selection and key management policy
    • Algorithms: ECDSA P-256 (signatures), AES-256-GCM (encryption), SHA-256 (hashing)
    • Key lifecycle: Generation, storage (HSM), rotation (annual), revocation, destruction
    • Document: Cryptographic Standards Policy (CODITECT-BIO-CRYPTO-001)
    • Evidence: docs/compliance/crypto-standards-policy.md (1,301 lines)
  • D.1.2: Design HSM integration architecture for production key management
    • Provider: Google Cloud HSM or AWS CloudHSM
    • Keys: Signing keys, encryption keys, TLS certificates
    • Access: Role-based HSM access with audit logging
    • Evidence: docs/compliance/hsm-integration-architecture.md (2,086 lines)
  • D.1.3: Implement certificate chain for document signing
    • Root CA: CODITECT organizational root certificate
    • Intermediate: Per-organization intermediate CA
    • User certs: Per-user signing certificates issued by intermediate
    • Evidence: docs/compliance/certificate-chain-architecture.md (2,403 lines)
  • D.1.4: Create validation test suite for cryptographic operations
    • Tests: Signature creation/verification, hash computation, key pair generation
    • NIST vectors: Use NIST test vectors for algorithm validation
    • Performance: Benchmark signing operations (target: < 50ms per signature)
    • Evidence: docs/compliance/crypto-validation-test-suite.md (2,349 lines)

D.2: FDA 21 CFR Part 11 Validation​

Sprint: S4-S5 | Priority: P0 | Depends On: C.1, C.4, D.1 Goal: Full validation package for FDA electronic records/signatures compliance Reference: docs/architecture/17-e-signature-architecture.md

  • D.2.1: Create IQ/OQ/PQ validation protocol documents
    • IQ (Installation Qualification): Verify system installed correctly
    • OQ (Operational Qualification): Verify system operates as designed
    • PQ (Performance Qualification): Verify system performs under real conditions
    • Templates: Reusable templates per GAMP 5 methodology
    • Evidence: docs/compliance/fda-validation-protocols.md (2,711 lines)
  • D.2.2: Implement electronic record controls
    • Integrity: Records cannot be modified without audit trail
    • Retrieval: All records retrievable in human-readable form
    • Retention: Configurable retention periods per record type
    • Access: Role-based access with time-limited sessions
    • Evidence: docs/compliance/electronic-record-controls.md (2,657 lines)
  • D.2.3: Implement electronic signature controls
    • Binding: Signature bound to specific record version
    • Components: Two-factor (user ID + password + biometric optional)
    • Meaning: Signature meaning (author, reviewer, approver) recorded
    • Sequential: Signatures executed in required order
    • Evidence: docs/compliance/electronic-signature-controls.md (2,529 lines)
  • D.2.4: Create validation execution evidence package
    • Evidence: Test execution logs, screenshots, data integrity checks
    • Traceability: Requirements → design → test → evidence matrix
    • Deviations: Document any deviations with impact assessment
    • Evidence: docs/compliance/validation-evidence-package.md (1,531 lines)
  • D.2.5: Conduct validation review and approval
    • Review: QA review of all validation documentation
    • Approval: Formal sign-off by Quality Head
    • Report: Validation Summary Report (VSR)
    • Evidence: docs/compliance/validation-review-approval.md (1,601 lines)

D.3: HIPAA Security Controls​

Sprint: S5 | Priority: P1 | Depends On: C.1 Goal: HIPAA technical safeguards for organizations handling PHI Reference: docs/operations/64-security-architecture.md

  • D.3.1: Implement access controls for PHI data
    • Authentication: Multi-factor for PHI access
    • Authorization: Minimum necessary principle enforcement
    • Session: Auto-timeout after 15 minutes inactivity
    • Emergency: Break-glass procedure for emergency PHI access
    • Evidence: docs/compliance/hipaa-access-controls.md (2,343 lines)
  • D.3.2: Implement encryption for PHI at rest and in transit
    • At rest: AES-256-GCM column-level encryption for PHI fields
    • In transit: TLS 1.3 minimum for all API communication
    • Key management: Separate encryption keys per organization
    • Evidence: docs/compliance/hipaa-encryption-controls.md (1,719 lines)
  • D.3.3: Build BAA (Business Associate Agreement) management module
    • Model: BAA record with covered entity, effective date, termination provisions
    • Tracking: BAA status dashboard for compliance team
    • Alerts: Renewal notifications 90 days before expiry
    • Evidence: docs/compliance/baa-management-module.md (1,879 lines)
  • D.3.4: Create HIPAA audit and reporting capabilities
    • Audit log: All PHI access logged (who, what, when, where)
    • Reports: Access frequency reports, unusual access patterns
    • Breach: Breach notification workflow and timeline tracking
    • Evidence: docs/compliance/hipaa-audit-reporting.md (2,530 lines)

D.4: SOC 2 Compliance Implementation​

Sprint: S5-S6 | Priority: P1 | Depends On: C.1, D.3 Goal: SOC 2 Type II controls for Trust Service Criteria Reference: docs/compliance/compliance-readiness-matrix.md

  • D.4.1: Map SOC 2 Trust Service Criteria to system controls
    • Security: Logical access, network security, system monitoring
    • Availability: System redundancy, disaster recovery, capacity planning
    • Processing Integrity: QA processes, error handling, data validation
    • Confidentiality: Data classification, encryption, access restrictions
    • Evidence: docs/compliance/soc2-tsc-mapping.md (1,040 lines)
  • D.4.2: Implement continuous monitoring controls
    • Log aggregation: Centralized logging (Cloud Logging or ELK)
    • Alerting: Real-time alerts for security events
    • Dashboards: SOC 2 control effectiveness dashboard
    • Evidence: docs/compliance/soc2-continuous-monitoring.md (2,748 lines)
  • D.4.3: Create SOC 2 evidence collection automation
    • Scripts: Automated evidence collection for each control
    • Schedule: Monthly evidence snapshots
    • Storage: Tamper-evident evidence repository
    • Evidence: docs/compliance/soc2-evidence-automation.md (2,867 lines)
  • D.4.4: Prepare SOC 2 readiness assessment
    • Gap analysis: Current state vs SOC 2 requirements
    • Remediation plan: Priority-ordered gap closure tasks
    • Auditor prep: Pre-audit documentation package
    • Evidence: docs/compliance/soc2-readiness-assessment.md (1,579 lines)

D.5: Audit Trail & Evidence Package​

Sprint: S6 | Priority: P1 | Depends On: D.2-D.4 Goal: Comprehensive audit trail system and compliance evidence package

  • D.5.1: Implement immutable audit trail storage
    • Storage: Append-only table with cryptographic hash chain
    • Fields: Timestamp, user, action, resource, old_value, new_value, hash
    • Integrity: Periodic hash chain verification (daily cron)
    • Evidence: docs/compliance/immutable-audit-trail-storage.md (2,632 lines)
  • D.5.2: Create audit trail search and reporting API
    • Search: By user, resource, date range, action type
    • Export: CSV, PDF, JSON formats
    • Retention: Configurable per-regulation (Part 11: 7 years, HIPAA: 6 years)
    • Evidence: docs/compliance/audit-trail-search-reporting.md (2,764 lines)
  • D.5.3: Build compliance dashboard for ongoing monitoring
    • Metrics: Open CAPAs, overdue deviations, training compliance %, audit findings
    • Trends: Compliance KPIs over time
    • Alerts: Red/yellow/green status per compliance area
    • Evidence: docs/compliance/compliance-monitoring-dashboard.md (4,816 lines)
  • D.5.4: Package regulatory submission documentation
    • FDA: Computer System Validation (CSV) package
    • HIPAA: Security risk assessment documentation
    • SOC 2: Control description and evidence binder
    • Format: PDF with digital signatures and table of contents
    • Evidence: docs/compliance/regulatory-submission-documentation.md (3,149 lines)
  • D.5.5: Implement ALCOA+ format preservation controls
    • Legibility: document rendering guarantees across formats (PDF, HTML, print)
    • Original records: distinction between original, true copy, and certified copy
    • Amendment tracking: clear indication of original vs. amended content with reason
    • Enduring: format migration strategy ensuring readability over retention period
    • Evidence: docs/compliance/alcoa-plus-format-preservation.md (3,111 lines)
  • D.5.6: Build original/copy/amendment tracking system
    • Original flag: immutable original record identification
    • True copies: verified true copy generation with hash verification
    • Amendment chain: amendment history with before/after comparison
    • Certification: Compliance Officer certification of true copies
    • Evidence: docs/compliance/original-copy-amendment-tracking.md (2,791 lines)
  • D.5.7: Create accuracy monitoring dashboard
    • Data entry validation: real-time validation rules per field type
    • Transcription errors: detection using pattern analysis and cross-reference checks
    • Accuracy metrics: monthly accuracy rates per data category and user
    • Alerting: notification on accuracy rate below threshold (<99.5%)
    • Evidence: docs/compliance/accuracy-monitoring-dashboard.md (2,589 lines)
  • D.5.8: Implement legibility controls for long-term storage
    • Format validation: automatic format integrity check on archived records
    • Rendering verification: periodic rendering test of archived records
    • Migration: format migration tooling (e.g., TIFF → PDF/A when needed)
    • Accessibility: screen reader compatibility for electronic records
    • Evidence: docs/compliance/legibility-controls-long-term-storage.md (2,404 lines)

D.6: Multi-Tenancy & Tenant Lifecycle​

Sprint: S5 | Priority: P1 | Depends On: C.1, D.3 Goal: Complete tenant lifecycle management with provisioning, isolation, and GDPR-compliant deletion

  • D.6.1: Implement per-tenant encryption key management
    • Isolation: dedicated encryption keys per organization
    • Rotation: automated key rotation without downtime
    • Revocation: key revocation on tenant deletion (crypto-shredding)
    • Audit: key access logging per tenant
    • Evidence: docs/compliance/tenant-encryption-key-management.md (2,975 lines)
  • D.6.2: Build automated tenant provisioning workflow
    • Steps: database schema creation, key generation, storage allocation, initial config
    • Validation: provisioning health check (connectivity, permissions, encryption)
    • Timing: target <5 minutes for full provisioning
    • Rollback: automated cleanup on provisioning failure
    • Evidence: docs/compliance/tenant-provisioning-workflow.md (3,138 lines)
  • D.6.3: Create tenant deletion and data purge workflow
    • GDPR compliance: complete data erasure within 30 days of request
    • Regulatory hold: prevent deletion when regulatory retention applies
    • Crypto-shredding: key destruction as primary erasure mechanism
    • Verification: deletion verification report with attestation
    • Evidence: docs/compliance/tenant-deletion-workflow.md (3,527 lines)
  • D.6.4: Implement tenant data export and migration
    • Export formats: JSON, CSV, XML with full schema documentation
    • Completeness: export all tenant data including audit trails and attachments
    • Migration: tenant-to-tenant data migration tooling (for M&A scenarios)
    • Validation: export integrity verification (row counts, hash checks)
    • Evidence: docs/compliance/tenant-data-export-migration.md (3,073 lines)

D.7: Validation Execution & Management​

Sprint: S5-S6 | Priority: P1 | Depends On: D.2 Goal: Automated validation execution framework with evidence collection and periodic re-validation

  • D.7.1: Build validation test execution framework
    • Automation: scripted IQ/OQ/PQ test execution with evidence capture
    • Screenshots: automated screenshot capture at each test step
    • Data integrity: automated verification of data integrity controls
    • Regression: re-run validation suite on system updates
    • Evidence: docs/compliance/validation-test-framework.md (2,384 lines)
  • D.7.2: Create validation approval and sign-off workflow
    • Roles: Test Executor, QA Reviewer, Quality Head Approver
    • Electronic signatures: Part 11 compliant e-signatures per approval step
    • Deviation handling: deviation documentation and impact assessment
    • Report: auto-generated Validation Summary Report (VSR)
    • Evidence: docs/compliance/validation-approval-workflow.md (2,129 lines)
  • D.7.3: Implement validation binder assembly automation
    • Binder structure: protocols, test scripts, evidence, deviations, summary report
    • Assembly: automated compilation of all validation artifacts
    • Export: PDF binder with hyperlinked table of contents
    • Versioning: binder version control with change tracking
    • Evidence: docs/compliance/validation-binder-assembly.md (4,091 lines)
  • D.7.4: Build periodic re-validation scheduling
    • Triggers: time-based (annual), change-based (major updates), event-based (incidents)
    • Scope: risk-based re-validation scope determination
    • Calendar: re-validation calendar with automated reminders
    • Evidence: re-validation evidence linked to original validation
    • Evidence: docs/compliance/periodic-revalidation-scheduling.md (2,320 lines)

Updated: 2026-02-16 Compliance: CODITECT Track Nomenclature Standard (ADR-054)