VP-001: Validation Plan¶
| Property | Value |
|---|---|
| ID | VP-001 |
| Version | 1.0 |
| Status | Draft |
| Product | Essert.MF (Microfactory) |
| GAMP5 Category | 4 — Configured Product |
| Author | |
| Approved By | |
| Date |
1. Purpose¶
This Validation Plan defines the strategy, scope, and responsibilities for validating the Essert.MF standard product in accordance with GAMP5 guidelines for Category 4 (Configured Products).
Essert.MF is a standardized, configurable manufacturing execution system deployed across multiple pharmaceutical/medical device production projects. Validation focuses on verifying that the standard product functions correctly and that configurations meet requirements.
2. Scope¶
2.1 In Scope¶
- Validation of the Essert.MF standard product
- All 5 bounded contexts: Manufacturing, Product, Quality, Robot, WorkPieceCarrier
- Cross-cutting concerns: Parameter Management, System Configuration, Integration, Data Integrity
- All API protocols: REST, OPC UA, GraphQL
- All 8 database contexts
2.2 Out of Scope¶
- Project-specific configuration validation (responsibility of each deployment project)
- Hardware qualification (PLC, robots, vision systems)
- Network infrastructure qualification
- Third-party library validation (covered by supplier assessment)
3. Regulatory Basis¶
| Standard | Applicability |
|---|---|
| GAMP5 2nd Edition (ISPE) | Primary validation framework — Category 4 approach |
| FDA 21 CFR Part 11 | Electronic records and signatures |
| EU Annex 11 | Computerised systems in GMP environments |
| FDA CSA Guidance (2025) | Risk-based testing approach (critical thinking) |
| ICH Q9 | Quality risk management for risk assessment methodology |
4. Validation Strategy¶
4.1 Category 4 Approach¶
As a Category 4 configured product, the validation strategy focuses on:
- Supplier qualification: Essert demonstrates a controlled SDLC (version control, code review, automated testing, release management)
- Product validation: The standard product is validated once through comprehensive testing (IQ/OQ/PQ)
- Configuration validation: Each project validates its specific configuration (out of scope for this plan)
4.2 Risk-Based Testing (FDA CSA)¶
Following FDA CSA guidance, testing effort is proportional to GxP risk:
| Risk Level | Testing Approach | Example |
|---|---|---|
| High | Scripted test cases with full traceability | Data integrity (CRC), transaction atomicity |
| Medium | Documented test cases, automated verification | CRUD operations, state transitions |
| Low | Automated test suite as evidence | Search, list, health checks |
4.3 V-Model Lifecycle¶
Specification (Left) Qualification (Right)
───────────────────── ─────────────────────
URS (User Requirements) <-> PQ (Performance Qualification)
FS (Functional Spec) <-> OQ (Operational Qualification)
DS (Design Spec) <-> IQ (Installation Qualification)
Cross-cutting: Risk Assessment (RA-001) and Traceability Matrix (RTM-001)
5. Validation Deliverables¶
| Phase | Document | Reference |
|---|---|---|
| Planning | VP-001 Validation Plan | This document |
| Requirements | URS-MFG/PRD/QUA/ROB/WPC/PAR/SYS/INT/DAT-001 | URS/ |
| Risk Assessment | RA-001 Risk Assessment | RA/ |
| Functional Spec | FS-MFG/PRD/QUA/ROB/WPC/PAR/SYS/INT/DAT-001 | FS/ |
| Design Spec | DS-001, DS-002, DS-003 | DS/ |
| Traceability | RTM-001 Traceability Matrix | RTM/ |
| Installation | IQ-001 Installation Qualification | QP/ |
| Operational | OQ-001 Operational Qualification | QP/ |
| Performance | PQ-001 Performance Qualification | QP/ |
| Validation Report | VR-001 (created after qualification) | — |
6. Roles and Responsibilities¶
| Role | Responsibility |
|---|---|
| Product Owner | Approve URS, accept validation results |
| Software Architect | Maintain FS, DS, ensure architecture compliance |
| Development Team | Implement features, maintain automated tests, update GAMP5 docs |
| Quality Assurance | Review validation deliverables, approve qualification protocols |
| Validation Lead | Coordinate validation activities, maintain RTM |
7. Test Infrastructure¶
The standard product validation leverages existing automated test infrastructure:
| Qualification | Test Source | Test Count | Command |
|---|---|---|---|
| IQ | DbContext tests, SchemaAnalyzer, Build | ~20 | dotnet build && dotnet test --filter "DbContext" |
| OQ | Domain + Application + Infrastructure + API tests | 1,551+ | dotnet test |
| PQ | Performance Benchmark CLI | 89 benchmarks | cd PerformanceBenchmarkCli && dotnet run -- run |
See arc42/10 - Quality Scenarios for performance thresholds and test coverage requirements.
8. Change Control¶
Changes to the validated standard product follow this process:
- Change Request: Document the change using Change Request Template
- Impact Analysis: Identify affected URS/FS items via RTM-001
- Risk Assessment: Update RA-001 if GxP risk changes
- Implementation: Follow development workflow (CLAUDE.md)
- Testing: Run full test suite — all tests must pass
- Documentation: Update affected FS, RTM entries
- Release: Version the product, update validation report
9. Deviation Handling¶
Any deviations from expected results during qualification must be:
- Documented with deviation ID, description, and impact assessment
- Classified as: Critical (blocks validation), Major (requires resolution), Minor (acceptable with justification)
- Resolved before validation completion (Critical/Major) or documented with risk acceptance (Minor)
10. References¶
- arc42 Architecture Documentation
- arc42/02 - Constraints (OC-03: GAMP5 Category 4)
- arc42/10 - Quality Scenarios
- CLAUDE.md - Development Workflow
Supporting Evidence (Archived)¶
- Testing Strategy — Pre-GAMP5 testing strategy, test pyramid, and best practices documentation