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Track F: Documentation & Training

Priority: ONGOING — Continuous across all sprints Agent: codi-documentation-writer Sprint Range: S3+

Status Summary​

Progress: 100% (24/24 tasks)

SectionTitleStatusTasks
F.1User DocumentationComplete5/5
F.2API DocumentationComplete4/4
F.3Admin & Compliance DocsComplete4/4
F.4Training MaterialsComplete5/5
F.5Document Inventory UpdatesComplete2/2
F.6Training Record Management & QualificationComplete4/4

F.1: User Documentation​

Sprint: S3+ | Priority: P1 | Depends On: A.1-A.3 (viewer), C.1-C.2 (backend) Goal: End-user documentation for QMS operators

  • F.1.1: Create Getting Started guide (evidence: docs/documentation/user-documentation.md §F.1.1)
    • Content: System access, navigation, first document creation
    • Audience: New QMS users (QA specialists, lab technicians)
    • Format: Step-by-step with screenshots
  • F.1.2: Create Document Management user guide (evidence: docs/documentation/user-documentation.md §F.1.2)
    • Content: Create, edit, review, approve documents
    • Workflows: Document lifecycle, version control, controlled copies
    • Tips: Best practices for effective document management
  • F.1.3: Create CAPA Management user guide (evidence: docs/documentation/user-documentation.md §F.1.3)
    • Content: Creating CAPAs, investigation workflow, corrective actions
    • Workflows: Full CAPA lifecycle with state machine diagram
    • Examples: Sample CAPA with investigation report
  • F.1.4: Create Deviation Management user guide (evidence: docs/documentation/user-documentation.md §F.1.4)
    • Content: Recording deviations, classification, investigation, resolution
    • Integration: How deviations link to CAPAs
    • SLAs: Response time expectations per severity
  • F.1.5: Create Search & Reporting user guide (evidence: docs/documentation/user-documentation.md §F.1.5)
    • Content: Using search, running reports, exporting data
    • Reports: Standard reports (overdue CAPAs, open deviations, training compliance)
    • Custom: Building custom queries and dashboards

F.2: API Documentation​

Sprint: S4+ | Priority: P1 | Depends On: C.1, C.5 Goal: Developer documentation for API integrators

  • F.2.1: Generate OpenAPI specification documentation (evidence: docs/documentation/api-documentation.md §F.2.1)
    • Source: Auto-generated from NestJS @ApiProperty decorators
    • Hosting: Swagger UI at /api/docs, ReDoc at /api/reference
    • Versioning: Per API version (v1, v2, etc.)
  • F.2.2: Create API authentication guide (evidence: docs/documentation/api-documentation.md §F.2.2)
    • Content: OAuth2 flow, JWT tokens, API key management
    • Examples: cURL, Python, JavaScript code samples
    • SDKs: Auto-generated client SDKs (TypeScript, Python)
  • F.2.3: Create webhook integration guide (evidence: docs/documentation/api-documentation.md §F.2.3)
    • Content: Event types, payload formats, delivery guarantees
    • Setup: Step-by-step webhook configuration
    • Testing: Test endpoint for webhook debugging
  • F.2.4: Create integration cookbook with code examples (evidence: docs/documentation/api-documentation.md §F.2.4)
    • Recipes: ERP sync, LIMS integration, document import, custom workflows
    • Languages: TypeScript, Python, cURL examples
    • Postman: Postman collection with all endpoints

F.3: Admin & Compliance Docs​

Sprint: S5+ | Priority: P1 | Depends On: D.2-D.5 Goal: Administrator guides and compliance documentation

  • F.3.1: Create System Administrator guide (evidence: docs/documentation/admin-compliance-documentation.md §F.3.1)
    • Content: User management, role configuration, organization settings
    • Advanced: SSO setup, API key management, backup procedures
    • Troubleshooting: Common issues and resolutions
  • F.3.2: Create Compliance Officer guide (evidence: docs/documentation/admin-compliance-documentation.md §F.3.2)
    • Content: Audit trail review, compliance dashboards, evidence collection
    • Regulations: FDA Part 11, HIPAA, SOC 2 specific procedures
    • Reporting: Compliance report generation and interpretation
  • F.3.3: Create Validation Protocol documentation (evidence: docs/documentation/admin-compliance-documentation.md §F.3.3)
    • IQ/OQ/PQ: Validation protocol templates
    • Execution: How to execute validation tests
    • Evidence: Evidence collection and packaging procedures
  • F.3.4: Create Regulatory Submission documentation package (evidence: docs/documentation/admin-compliance-documentation.md §F.3.4)
    • FDA: CSV (Computer System Validation) package
    • Content: System description, risk assessment, validation summary
    • Format: Structured PDF per regulatory submission guidelines

F.4: Training Materials​

Sprint: S6+ | Priority: P2 | Depends On: F.1-F.3 Goal: Training curriculum for different user roles

  • F.4.1: Create role-based training curriculum (evidence: docs/documentation/training-materials.md §F.4.1)
    • Roles: QA Manager, QA Specialist, Auditor, Lab Technician, IT Admin
    • Modules: Per-role training paths with prerequisites
    • Assessment: Knowledge check questions per module
  • F.4.2: Create video tutorial scripts (evidence: docs/documentation/training-materials.md §F.4.2)
    • Topics: Getting started, CAPA workflow, document management, admin setup
    • Format: Script with screen recording instructions
    • Length: 3-5 minutes per tutorial
  • F.4.3: Create SOPs for platform operations (evidence: docs/documentation/training-materials.md §F.4.3)
    • SOPs: System backup, user provisioning, compliance monitoring, incident response
    • Format: Standard SOP template with version control
    • Review: Annual review cycle per SOP
  • F.4.4: Create GxP-specific training modules (evidence: docs/documentation/training-materials.md §F.4.4)
    • Topics: Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP)
    • Regulatory: FDA, EU GMP Annex 11, ICH Q10 quality system
    • Assessment: knowledge verification exam per GxP module
    • Certification: GxP certification badge per role
  • F.4.5: Build qualification prerequisites system (evidence: docs/documentation/training-materials.md §F.4.5)
    • Mapping: training prerequisites per role and permission level
    • Enforcement: cannot access regulated features until prerequisites complete
    • Tracking: prerequisite completion dashboard per organization
    • Compliance: alignment with 21 CFR Part 211 training requirements

F.5: Document Inventory Updates​

Sprint: Ongoing | Priority: P2 | Depends On: All tracks Goal: Keep document inventory current as new artifacts are created

  • F.5.1: Update document inventory after each sprint (evidence: docs/documentation/inventory-training-records.md §F.5.1)
    • File: docs/reference/30-document-inventory.md
    • Action: Add new artifacts, update counts, verify categories
    • Frequency: End of each sprint
  • F.5.2: Update publish.json manifest after new documents (evidence: docs/documentation/inventory-training-records.md §F.5.2)
    • Script: Run scripts/generate-publish-manifest.js
    • Verify: New documents appear in viewer navigation
    • Frequency: After any document creation/deletion

F.6: Training Record Management & Qualification​

Sprint: S8 | Priority: P1 | Depends On: F.4, C.1 Goal: Complete training record system with qualification tracking, expiry management, and competency verification

  • F.6.1: Build training record management system (evidence: docs/documentation/inventory-training-records.md §F.6.1)
    • Records: per-user training history with completion dates and scores
    • Evidence: training completion certificates and exam results
    • Import: bulk import from existing training systems (CSV)
    • Reporting: training compliance rate per organization, role, module
  • F.6.2: Implement qualification expiry and renewal tracking (evidence: docs/documentation/inventory-training-records.md §F.6.2)
    • Expiry rules: configurable per qualification type (1yr, 2yr, 3yr)
    • Notifications: 90, 60, 30, 7 day reminders before expiry
    • Grace period: configurable grace period with restricted access
    • Renewal: streamlined re-certification workflow (refresher vs. full)
  • F.6.3: Create competency verification before role assignment (evidence: docs/documentation/inventory-training-records.md §F.6.3)
    • Gate: role assignment blocked until required training complete
    • Verification: automated check against role-training matrix
    • Override: QA Manager override with documented justification
    • Audit: all role assignments logged with training verification evidence
  • F.6.4: Build annual training refresher automation (evidence: docs/documentation/inventory-training-records.md §F.6.4)
    • Calendar: automated annual refresher scheduling per regulation
    • Content: delta training for updated SOPs and regulations
    • Tracking: refresher compliance rate with escalation for overdue
    • Reporting: annual training summary report for regulatory auditors

Updated: 2026-02-14 Compliance: CODITECT Track Nomenclature Standard (ADR-054)