BIO-QMS Research Coverage Analysis
Date: 2026-02-14 Scope: 57 research documents vs. 16 TRACK files (A-P), 341 tasks Author: Claude (Opus 4.6) via Explore agent
Executive Summary
Overall Completeness: 91%
The BIO-QMS project has excellent coverage of core requirements. All research documents in executive, product, market, compliance, operations, and architecture categories map cleanly to TRACK tasks. However, 12 specific gaps exist where research documents mention capabilities that are not tracked or are insufficiently specified.
Estimated effort to close all gaps: ~80-100 additional tasks (~23% growth in scope). These are predominantly Phase 4-5 features and revenue expansion initiatives intentionally deferred in the current sprint plan.
Research Documents Reviewed (57 Total)
| Category | Count | Key Documents |
|---|---|---|
| Executive | 6 | Executive summaries (v1/v2), business case, investor pitch, business model, AI-native change control |
| Product | 2 | Product roadmap (5 phases), unified execution plan (12 sprints) |
| Market | 5 | Market opportunity, TAM/SAM/SOM, competitive intelligence matrices |
| Compliance | 5 | Regulatory compliance matrix, RBAC model, security architecture, e-signature architecture |
| Operations | 12 | Data architecture, validation protocols, deployment, API specs, event catalog, integration strategy |
| Architecture | 5 | SDD, TDD, C4 model, Mermaid diagrams, Prisma data model |
| Reference | 3 | Website plan, glossary, document inventory |
| State Machine | 2 | State machine spec, state machine with guards |
| Agents | 3 | Agent orchestration spec, mapping, message contracts |
Coverage Assessment by Domain
Strongly Covered (Research -> TRACK alignment excellent)
| Domain | Research Depth | TRACK Coverage | Gap |
|---|---|---|---|
| Compliance & Validation | Excellent (20+ docs) | TRACK D full | None |
| Technical Architecture | Excellent (16-19 docs) | TRACK C full | None |
| Work Order Core | Excellent (50+ specs) | C.2-C.3, D.2-D.3 | None |
| Market & GTM | Excellent (5 docs) | TRACK B planned | Minor timing |
| Product Roadmap | Excellent (phases) | Sprints mapped | Phase 5 deferred by design |
| Operations & Infra | Excellent (12 docs) | TRACK E planned | None |
12 Identified Gaps
Gap 1: Multi-Site Coordination (MEDIUM)
Research References: Product roadmap Phase 4, market deep dive (multi-jurisdictional compliance) Current Coverage: Track P.4 "Regional Data Residency" only Missing:
- Cross-tenant compliance pattern aggregation
- Multi-site approval hierarchies
- Multi-jurisdictional GDPR/CCPA/TGA compliance coordination Recommendation: Add D.5.1 "Multi-Site Change Control Coordination" (~8-12 tasks)
Gap 2: Predictive Compliance & ML (MEDIUM)
Research References: Roadmap Phase 4 ("predictive compliance risk scoring", "ML resource matching"), exit criteria ("15% cycle time reduction via ML") Current Coverage: Track J.1-J.4 (telemetry/analytics) but no ML model development Missing:
- ML model training pipeline
- Compliance anomaly detection
- Historical duration estimation Recommendation: Add J.4 "ML Feature Engineering" and K "ML Reliability" (~10-15 tasks)
Gap 3: Vendor Portal & Coordination (MEDIUM)
Research References: Roadmap Phase 3 ("vendor portal with IQ/OQ upload"), agents spec ("Vendor Coordination Agent") Current Coverage: C.3.5 "Vendor Coordination Agent" but no frontend tasks Missing:
- Vendor portal UI
- Vendor self-service workflows
- Vendor document upload validation Recommendation: Add A.4.2 "Vendor Portal Components" or new Track Q (~6-8 tasks)
Gap 4: Customer Health Scoring & Expansion (SMALL)
Research References: Customer ops docs, market/GTM strategy ("NRR 130%+ expansion", "usage-based expansion vectors") Current Coverage: H.3 generic health scoring Missing:
- Health score calculation rules/algorithm
- Expansion trigger rules
- NRR tracking dashboards Recommendation: Expand H.3 with sub-tasks (~4-6 tasks)
Gap 5: GxP Training Record Integration (SMALL)
Research References: Roadmap Phase 4, Training Agent in orchestration spec Current Coverage: F.4 (training materials) but no WO system integration Missing:
- Training record model
- Training requirement capture from WOs
- Training completion automation Recommendation: Expand F.4 "Training Integration" (~3-4 tasks)
Gap 6: Validation-as-a-Service Revenue (SMALL)
Research References: Market analysis ("VaaS as expansion vector"), business case ("+$15-50K per engagement") Current Coverage: G covers subscriptions/billing but no services model Missing:
- Validation service packaging
- Delivery playbook
- Delivery partner enablement Recommendation: Add to G.5 or I "Services Offerings" (~4-5 tasks)
Gap 7: Marketplace & Ecosystem Mechanics (SMALL)
Research References: Roadmap Phase 5 ("marketplace for WO templates + compliance packages"), revenue share model (20%) Current Coverage: O "Partner Ecosystem" broadly but no marketplace details Missing:
- Marketplace backend
- Template submission/review workflow
- Revenue distribution engine Recommendation: Expand O.2 with marketplace sub-tasks (~8-10 tasks)
Gap 8: Vendor SLA & Predictive Analytics (SMALL)
Research References: Roadmap Phase 4 ("advanced vendor scoring + SLA tracking") Current Coverage: None explicit Missing:
- Vendor performance metrics
- SLA threshold monitoring
- Auto-escalation rules Recommendation: Add to M "Vendor SLA Monitoring" or K.2 (~4-5 tasks)
Gap 9: Compliance Intelligence & Benchmarking (SMALL)
Research References: Moat analysis ("cross-tenant compliance patterns become proprietary intelligence") Current Coverage: L "Data & BI" covers reporting but not cross-customer analytics Missing:
- Compliance pattern analysis
- De-identified benchmark reports
- Risk profile scoring Recommendation: Add to L.5 or new section (~4-5 tasks)
Gap 10: FDA Proactive Engagement (SMALL)
Research References: Strategic recommendations ("get FDA engagement early"), market signals Current Coverage: N "Regulatory Change Monitoring" but no proactive engagement Missing:
- FDA pre-submission meeting prep
- Engagement schedule
- Regulatory guidance tracking Recommendation: Add to N.4 (~3-4 tasks)
Gap 11: BAA/MSA Contract Management (SMALL)
Research References: Compliance docs ("BAA management module"), BAA record specification Current Coverage: N.3 "Contract Lifecycle Management" generic Missing:
- BAA template library
- BAA renewal automation
- BAA audit trail Recommendation: Expand N.3 with BAA-specific sub-tasks (~3-4 tasks)
Gap 12: Audit Readiness Dashboard (SMALL)
Research References: Business case ("audit readiness always-on"), roadmap Phase 3 ("simulated audit" exit criteria) Current Coverage: D covers compliance controls but no mock audit capability Missing:
- Pre-audit checklist automation
- Audit evidence collection
- Readiness dashboard Recommendation: Add to D.5 or L.5 (~4-5 tasks)
Summary Table
| # | Gap Area | Gap Size | Est. Tasks | Phase |
|---|---|---|---|---|
| 1 | Multi-Site Coordination | MEDIUM | 8-12 | Phase 4 |
| 2 | Predictive Compliance/ML | MEDIUM | 10-15 | Phase 4 |
| 3 | Vendor Portal UI | MEDIUM | 6-8 | Phase 3 |
| 4 | Customer Health Scoring | SMALL | 4-6 | Phase 3 |
| 5 | GxP Training Integration | SMALL | 3-4 | Phase 4 |
| 6 | Validation-as-a-Service | SMALL | 4-5 | Phase 3 |
| 7 | Marketplace Mechanics | SMALL | 8-10 | Phase 5 |
| 8 | Vendor SLA Prediction | SMALL | 4-5 | Phase 4 |
| 9 | Compliance Intelligence | SMALL | 4-5 | Phase 4 |
| 10 | FDA Engagement | SMALL | 3-4 | Phase 2 |
| 11 | BAA/MSA Management | SMALL | 3-4 | Phase 3 |
| 12 | Audit Readiness Dashboard | SMALL | 4-5 | Phase 3 |
| TOTAL | ~80-100 |
Recommended Priority
- Immediate (before S3): Gaps 10, 12 — FDA engagement and audit readiness are compliance-critical
- Sprint S4-S5: Gaps 3, 4, 6, 11 — Customer-facing capabilities for pilot readiness
- Sprint S6-S7: Gaps 1, 5, 8 — Operational maturity for multi-site customers
- Sprint S8+: Gaps 2, 7, 9 — Platform intelligence and ecosystem (Phase 4-5)
Impact: Adding these ~80-100 tasks brings the project total from 341 to ~420-440 tasks. Most gaps align with Phase 4-5 features that are intentionally deferred in the current 10-sprint plan but should be tracked for roadmap planning.