Project Status Brief (Auto-Generated)

Generated: 2026-02-17T03:10:35.087Z Project: coditect-biosciences-qms-platform

Summary

• Overall: 33% (137/410 tasks)
• Tracks: 17 total | 1 active | 0 in-progress | 12 planned | 4 complete
• Sections: 87 total | 23 complete | 0 in-progress | 64 pending
• Velocity: 45.7 tasks/day | high trend | ~6 days remaining | 3 active work days

Tracks

Track	Name	Status	Progress	Sections	Sprint
A	Presentation & Publishing	complete	100% (34/34)	6C/0P/0W	S1-S3
B	Competitive Intelligence & GTM	complete	100% (28/28)	5C/0P/0W	S2-S3
C	Technical Foundation	complete	100% (42/42)	5C/0P/0W	S3-S6
D	Compliance & Security	complete	100% (33/33)	7C/0P/0W	S3-S6
E	Operations & Deployment	planned	0% (0/20)	0C/0P/5W	S5-S6
F	Documentation & Training	active	0% (0/24)	0C/0P/6W	S3+
G	Revenue & Billing Operations	planned	0% (0/24)	0C/0P/5W	S5-S7
H	Customer Operations	planned	0% (0/24)	0C/0P/5W	S5-S8
I	Sales & Business Development	planned	0% (0/20)	0C/0P/5W	S4-S7
J	Product Management & Analytics	planned	0% (0/22)	0C/0P/5W	S6-S8
K	Platform Reliability & Maintenance	planned	0% (0/24)	0C/0P/6W	S6-S9
L	Data & Business Intelligence	planned	0% (0/22)	0C/0P/5W	S7-S9
M	Security Operations	planned	0% (0/18)	0C/0P/5W	S6-S9
N	Legal & Regulatory Operations	planned	0% (0/26)	0C/0P/5W	S5-S8
O	Partner Ecosystem	planned	0% (0/19)	0C/0P/4W	S8-S10
P	Accessibility & Internationalization	planned	0% (0/18)	0C/0P/5W	S4-S10
Q	AI & Automation Governance	planned	0% (0/12)	0C/0P/3W	S8-S10

At-Risk Tracks (0% Progress)

• E Operations & Deployment: 20 tasks, status=planned, sprint=S5-S6
• F Documentation & Training: 24 tasks, status=active, sprint=S3+
• G Revenue & Billing Operations: 24 tasks, status=planned, sprint=S5-S7
• H Customer Operations: 24 tasks, status=planned, sprint=S5-S8
• I Sales & Business Development: 20 tasks, status=planned, sprint=S4-S7
• J Product Management & Analytics: 22 tasks, status=planned, sprint=S6-S8
• K Platform Reliability & Maintenance: 24 tasks, status=planned, sprint=S6-S9
• L Data & Business Intelligence: 22 tasks, status=planned, sprint=S7-S9
• M Security Operations: 18 tasks, status=planned, sprint=S6-S9
• N Legal & Regulatory Operations: 26 tasks, status=planned, sprint=S5-S8
• O Partner Ecosystem: 19 tasks, status=planned, sprint=S8-S10
• P Accessibility & Internationalization: 18 tasks, status=planned, sprint=S4-S10
• Q AI & Automation Governance: 12 tasks, status=planned, sprint=S8-S10

Cross-Track Dependencies

• Viewer foundation: A.1 → A.2, A.3, P.1 (Markdown rendering before nav/search/a11y)
• Cloud platform: A.4 → A.5 (Deploy before auth)
• Competitive data: B.1 → B.2, I.2 (Market analysis before GTM and sales collateral)
• Backend scaffold: C.1 → C.2-C.5, G.1, H.1-H.2, J.1, N.2 (API framework before all backend features)
• State machine: C.2 → J.3 (WO engine before WO analytics)
• Integrations: C.5 → O.2, O.3 (Integration layer before marketplace/SDK)
• Crypto foundation: D.1 → C.4, M.4 (Gap closure before e-sig and secrets mgmt)
• HIPAA controls: D.3 → N.2, N.3 (HIPAA before GDPR engine and BAA management)
• CI/CD pipeline: E.1 → M.1, K.3 (Pipeline before security scanning and patching)
• Infrastructure: E.2 → K.1, L.1, P.4 (GCP before SLA monitoring, data warehouse, regions)
• Monitoring: E.3 → K.1-K.2, M.3 (Observability before SLA/incident management)
• Subscriptions: G.1 → G.2-G.5, H.3 (Subscription model before pricing/billing/health)
• Payments: G.3 → H.4, I.4 (Payment processing before billing portal/contracts)
• CRM: I.1 → I.3-I.5, H.3 (CRM before assessment tool, proposals, partner mgmt)
• Telemetry: J.1 → J.2-J.4 (Event tracking before analytics/experimentation)
• Partner program: I.5, O.1 → O.2-O.4 (Foundation before marketplace/SDK/analytics)
• i18n framework: P.2 → P.3, P.4 (i18n before localization and regional data)
• AI governance: Q.1 → Q.2-Q.3 (Model governance before AI testing/risk mgmt)
• Agent framework: C.3 → Q.1 (Agent orchestration before AI governance)
• Data warehouse: L.1 → Q.2 (Warehouse before AI model monitoring data)
• Validation: D.7 → Q.2 (Validation framework before AI validation)
• Tenant lifecycle: D.6 → H.1, G.1 (Tenant provisioning before onboarding/billing)
• DR automation: E.5 → K.5 (DR validation before chaos engineering)
• Training records: F.6 → D.2 (Training records for Part 11 compliance)
• Multi-site: K.6 → O.1 (Site management before partner coordination)
• All tracks: * → F.* (Documentation continuous across all work)

Sprint Load

• S1 (Wk 1-2): Presentation + Doc Verification — 7 sections
• S2 (Wk 3-4): Cloud Publishing + Competitive Analysis — 5 sections
• S3 (Wk 5-6): Auth + GTM + Foundation Start — 8 sections
• S4 (Wk 7-8): Backend Core + Sales Enablement — 7 sections
• S5 (Wk 9-10): Agents + Integrations + Billing — 9 sections
• S6 (Wk 11-12): Ops + Payments + Data Warehouse — 16 sections
• S7 (Wk 13-14): Analytics + Monitoring + Reliability — 26 sections
• S8 (Wk 15-16): Docs + BI + Marketplace + AI Governance — 24 sections
• S9 (Wk 17-18): Patching + Resilience + Vulnerability — 10 sections
• S10 (Wk 19-20): Final Polish — 24 sections

Agent Workload

• frontend-react-typescript-expert: 1 tracks
• competitive-analyst: 1 tracks
• senior-architect: 1 tracks
• security-specialist: 1 tracks
• devops-engineer: 1 tracks
• codi-documentation-writer: 1 tracks
• payment-systems-specialist: 1 tracks
• customer-onboarding: 1 tracks
• sales-workflow: 1 tracks
• product-analytics-specialist: 1 tracks
• sre-on-call-assistant: 1 tracks
• data-pipeline-specialist: 1 tracks
• incident-response-specialist: 1 tracks
• regulatory-change-monitor: 1 tracks
• partner-onboarding: 1 tracks
• accessibility-testing-specialist: 1 tracks
• responsible-ai: 1 tracks

Recent Session Logs

• 2026-02-16 — BIO-QMS
• 2026-02-15 — BIO-QMS
• 2026-02-14 — BIO-QMS

Completed Work (Active Tracks)

A: Presentation & Publishing (34 done)

• A.1.1: Install unified/remark/rehype markdown pipeline
• A.1.2: Create MarkdownRenderer.jsx component with frontmatter extraction
• A.1.3: Build publish.json manifest generator from docs/ directory tree
• A.1.4: Extend viewer.jsx to route markdown docs alongside JSX dashboards
• A.1.5: Implement hash-based URL routing (/#/audience/category/document)
• A.1.6: Add print-friendly CSS and document metadata display
• A.2.1: Integrate MiniSearch for client-side full-text search
• A.2.2: Build search index from all markdown content at build time
• A.2.3: Create sidebar navigation tree from publish.json categories
• A.2.4: Add breadcrumb navigation and document table of contents
• A.2.5: Implement keyboard shortcuts (/, Ctrl+K for search)
• A.3.1: Fullscreen presentation mode with minimal chrome
• A.3.2: Keyboard navigation (arrows for prev/next, Escape to exit)
• A.3.3: Section-by-section slide progression within documents
• A.3.4: Presentation timer and progress indicator
• A.4.1: Create publish.json schema and validation
• A.4.2: Build static site generator from Vite configuration
• A.4.3: Create Cloud Run deployment configuration
• A.4.4: Implement environment-based auth mode switching
• A.4.5: Create deployment script (scripts/deploy.sh)
• A.4.6: Implement CDN caching with Cloud CDN
• A.4.7: Add custom domain and SSL configuration
• A.4.8: Create publish CLI command for one-click deployment
• A.5.1: Implement NDARecord Django model in auth.coditect.ai
• A.5.2: Implement DocumentViewToken Django model
• A.5.3: Create NDA verification API endpoints
• A.5.4: Implement client-side auth flow in viewer
• A.5.5: Build audit trail for document access
• A.5.6: Implement token revocation and admin controls
• A.5.7: Create local bypass mode for development/presentations
• A.6.1: Extract viewer core into @coditect/doc-viewer npm package
• A.6.2: Create project scaffolding CLI
• A.6.3: Publish to npm with semantic versioning
• A.6.4: Create customer onboarding documentation

B: Competitive Intelligence & GTM (28 done)

• B.0.1: Audit all TRACK-referenced documents for existence
• B.0.2: Create or update missing referenced documents
• B.0.3: Verify document cross-references are bidirectional
• B.0.4: Create document readiness gate for sprint start
• B.1.1: Execute Phase 1 Turn 1 — Market sizing (TAM/SAM/SOM)
• B.1.2: Execute Phase 1 Turn 2 — Customer segmentation & ICP
• B.1.3: Execute Phase 2 Turn 3 — Competitor profiling
• B.1.4: Execute Phase 2 Turn 4 — Moat & positioning
• B.1.5: Execute Phase 3 Turn 5 — Synthesis
• B.1.6: Update existing artifacts (05-10) with new competitive data
• B.1.7: Regenerate competitive-comparison dashboard (54.jsx)
• B.2.1: Execute Turn 1 — GTM model & revenue architecture
• B.2.2: Execute Turn 2 — Channel strategy & sales process
• B.2.3: Execute Turn 3 — Demand gen & content strategy
• B.2.4: Execute Turn 4 — Customer success & expansion
• B.2.5: Execute Turn 5 — Phased launch plan
• B.2.6: Execute Turn 6 — Metrics & dashboards
• B.2.7: Update 09-go-to-market-strategy.md
• B.2.8: Update 62-unified-execution-plan.md with GTM phases
• B.3.1: Execute impact register generation
• B.3.2: Identify cascade update requirements
• B.3.3: Generate impact visualization dashboard
• B.4.1: Audit existing market docs (05-10) against new analysis
• B.4.2: Update executive summary (01-executive-summary.md)
• B.4.3: Update investment thesis (02-executive-summary-updated.md)
• B.4.4: Update financial projections (03-business-case.md)
• B.4.5: Update document inventory (30-document-inventory.md)
• B.4.6: Regenerate publish.json manifest with new artifacts

C: Technical Foundation (42 done)

• C.1.1: Initialize NestJS project with TypeScript strict mode
• C.1.2: Configure Prisma ORM with PostgreSQL schema
• C.1.3: Implement authentication module (JWT + OAuth2)
• C.1.4: Implement RBAC authorization system
• C.1.5: Create base CRUD module with audit trail
• C.1.6: Set up database migrations and seeding
• C.1.7: Configure OpenAPI/Swagger documentation
• C.1.8: Set up testing framework (unit + integration)
• C.2.1: Implement XState workflow engine core (80/80 tests pass, 5 suites)
• C.2.2: Define CAPA state machine (54/54 tests pass)
• C.2.3: Define Deviation state machine (44/44 tests pass)
• C.2.4: Define Change Control state machine (50/50 tests pass, 196/196 full regression)
• C.2.5: Implement state transition API endpoints (239/239 tests pass)
• C.2.6: Add state machine visualization endpoint (264/264 tests pass)
• C.2.7: Implement change control regulatory classification (284/284 tests pass, 70 change control tests)
• C.2.8: Build deviation-to-change linking (306/306 tests pass, 22 cross-entity linking tests)
• C.2.9: Implement change effectiveness verification workflow ✅ 336/336 tests, 30 new
• C.2.10: Create change communication engine ✅ 360/360 tests, 24 new
• C.2.11: Design rollback testing per change type ✅ 386/386 tests, 26 new
• C.3.1: Implement agent execution engine ✅ 2026-02-15
• C.3.2: Create Document Analysis Agent ✅ 2026-02-15
• C.3.3: Create CAPA Investigation Agent ✅ 2026-02-15
• C.3.4: Create Compliance Monitoring Agent ✅ 2026-02-15
• C.3.5: Implement agent API and scheduling ✅ 2026-02-15
• C.3.6: Implement tenant-scoped context isolation ✅ 2026-02-15
• C.3.7: Build agent decision audit trail ✅ 2026-02-15
• C.3.8: Create coditect-core registry components for BIO-QMS agents ✅ 2026-02-15
• C.4.1: Implement cryptographic signing module
• C.4.2: Create electronic signature service
• C.4.3: Implement document integrity verification
• C.4.4: Create timestamping authority integration
• C.4.5: Build signature verification UI components
• C.5.1: Implement webhook event system
• C.5.2: Create ERP integration adapter
• C.5.3: Create LIMS integration adapter
• C.5.4: Create document management integration
• C.5.5: Implement API rate limiting and quotas
• C.5.6: Create integration testing suite
• C.5.7: Implement HL7 FHIR data exchange
• C.5.8: Build batch record traceability — 57 tests pass, 1067/1067 full regression
• C.5.9: Create Electronic Batch Record (EBR) generation — 41 tests pass, 1108/1108 full regression
• C.5.10: Implement quality hold automation — 35 tests pass, 1143/1143 full regression

D: Compliance & Security (33 done)

• D.1.1: Define cryptographic algorithm selection and key management policy
• D.1.2: Design HSM integration architecture for production key management
• D.1.3: Implement certificate chain for document signing
• D.1.4: Create validation test suite for cryptographic operations
• D.2.1: Create IQ/OQ/PQ validation protocol documents
• D.2.2: Implement electronic record controls
• D.2.3: Implement electronic signature controls
• D.2.4: Create validation execution evidence package
• D.2.5: Conduct validation review and approval
• D.3.1: Implement access controls for PHI data
• D.3.2: Implement encryption for PHI at rest and in transit
• D.3.3: Build BAA (Business Associate Agreement) management module
• D.3.4: Create HIPAA audit and reporting capabilities
• D.4.1: Map SOC 2 Trust Service Criteria to system controls
• D.4.2: Implement continuous monitoring controls
• D.4.3: Create SOC 2 evidence collection automation
• D.4.4: Prepare SOC 2 readiness assessment
• D.5.1: Implement immutable audit trail storage
• D.5.2: Create audit trail search and reporting API
• D.5.3: Build compliance dashboard for ongoing monitoring
• D.5.4: Package regulatory submission documentation
• D.5.5: Implement ALCOA+ format preservation controls
• D.5.6: Build original/copy/amendment tracking system
• D.5.7: Create accuracy monitoring dashboard
• D.5.8: Implement legibility controls for long-term storage
• D.6.1: Implement per-tenant encryption key management
• D.6.2: Build automated tenant provisioning workflow
• D.6.3: Create tenant deletion and data purge workflow
• D.6.4: Implement tenant data export and migration
• D.7.1: Build validation test execution framework
• D.7.2: Create validation approval and sign-off workflow
• D.7.3: Implement validation binder assembly automation
• D.7.4: Build periodic re-validation scheduling

Next Up (Pending Tasks in Active Tracks)

F: Documentation & Training (24 remaining)

• F.1.1: Create Getting Started guide
• F.1.2: Create Document Management user guide
• F.1.3: Create CAPA Management user guide
• F.1.4: Create Deviation Management user guide
• F.1.5: Create Search & Reporting user guide
• ... and 19 more

Section Detail (Active Tracks)

A: Presentation & Publishing

• [DONE] A.1 Viewer Enhancement — Markdown Rendering (6/6)
• [DONE] A.2 Navigation & Search (5/5)
• [DONE] A.3 Presentation Mode (4/4)
• [DONE] A.4 Cloud Publishing Platform (ADR-195) (8/8)
• [DONE] A.5 NDA-Gated Access Control (ADR-196) (7/7)
• [DONE] A.6 Multi-Project Reusable Package (4/4)

B: Competitive Intelligence & GTM

• [DONE] B.0 Pre-Sprint Document Verification (4/4)
• [DONE] B.1 Competitive Market Analysis (Prompt 76) (7/7)
• [DONE] B.2 GTM Strategy Generation (Prompt 77) (8/8)
• [DONE] B.3 Cross-Artifact Impact Register (Prompt 78) (3/3)
• [DONE] B.4 Artifact Reconciliation & Update (6/6)

C: Technical Foundation

• [DONE] C.1 Backend API Scaffold (NestJS/Prisma) (8/8)
• [DONE] C.2 State Machine Engine Implementation (11/11)
• [DONE] C.3 Agent Orchestration Framework (8/8)
• [DONE] C.4 E-Signature & Crypto Foundation (5/5)
• [DONE] C.5 Integration & API Layer (10/10)

D: Compliance & Security

• [DONE] D.1 Critical Gap Closure (Crypto/Signatures) (4/4)
• [DONE] D.2 FDA 21 CFR Part 11 Validation (5/5)
• [DONE] D.3 HIPAA Security Controls (4/4)
• [DONE] D.4 SOC 2 Compliance Implementation (4/4)
• [DONE] D.5 Audit Trail & Evidence Package (8/8)
• [DONE] D.6 Multi-Tenancy & Tenant Lifecycle (4/4)
• [DONE] D.7 Validation Execution & Management (4/4)

F: Documentation & Training

• [TODO] F.1 User Documentation (0/5)
• [TODO] F.2 API Documentation (0/4)
• [TODO] F.3 Admin & Compliance Docs (0/4)
• [TODO] F.4 Training Materials (0/5)
• [TODO] F.5 Document Inventory Updates (0/2)
• [TODO] F.6 Training Record Management & Qualification (0/4)

Recent Work (Session Log Excerpts)

2026-02-16:

• 2026-02-16T09:20:47Z — [D.1-D.7] Track D: Compliance & Security — Session Completion Summary
• 2026-02-16T10:35:08Z — [A.4.1-A.4.8] Track A.4: Cloud Publishing Platform — Session Start
• 2026-02-16T15:30:00Z — [ADR-196] NDARecord Django Model Technical Design Document
• 2026-02-16T11:10:52Z — [A.4.1-A.4.8, A.5.1-A.5.7] Track A Sections A.4 + A.5 Complete
• 2026-02-16T11:14:20Z — [A.6] Track A.6: Multi-Project Reusable Package — START
• 2026-02-16T11:30:00Z — [A.6.1-A.6.4] Track A Complete — 100% (34/34 tasks)
• 2026-02-16T11:35:00Z — [E.1-E.5] Track E: Operations & Deployment — START
• 2026-02-16T18:02:00Z — [J.18] Dashboard Consolidation — BIO-QMS becomes consumer 2026-02-15:
• 2026-02-15T10:45:00Z — [C.4.1-C.4.5] E-Signature & Crypto Foundation Complete
• 2026-02-15T10:50:00Z — [C.5] Session Start: Integration & API Layer
• 2026-02-15T11:30:00Z — [C.5.1] Webhook Event System Complete
• 2026-02-15T16:46:21Z — [C.5.2] ERP Integration Adapter Complete + API Research
• 2026-02-15T09:45:00Z — [C.5.3] LIMS Integration Adapter — Complete
• 2026-02-15T21:45:00Z — [C.5.4] Document Management Integration Complete
• 2026-02-15T10:45:00Z — [C.5.5] API Rate Limiting & Quotas Complete
• 2026-02-15T19:04:28Z — [H.0] Project Status Updated + Velocity Dashboard Bug Fix