Prototype — this is a working draft, shared for feedback and discussion. Not a finished, certified, or officially adopted framework. Scope — not intended for use as, or in the development of, a regulated medical device.
Home / Key Artifacts Matrix / Validate
Phase 5

Validate · Model Validation

Independently prove the system works — functional, security, AI/model, and formal GxP qualification testing, all traced back to source requirements.

7Artifacts
6Word
1Excel
System Test Protocol
Word
Incl. Agentic/LLM Security test type (OWASP)
Template coming soon
UAT Protocol
Word
Business/clinical acceptance, distinct from technical System Test
Template coming soon
Sample Test Scripts
Word
4 worked examples incl. TC-SEC-022 (prompt-injection test)
Template coming soon
IQ/OQ/PQ Qualification Protocol
Word
Combined GxP protocol (GAMP 5 risk-based approach); distinct from System Test Protocol
Template coming soon
Requirements Traceability Matrix (RTM)
Excel
Live formulas; Summary tab auto-totals Pass/Fail/Open
Template coming soon
Model Validation Report
Word
Independent re-validation; author must differ from developer
Template coming soon
Test Summary Report
Word
Consolidates System Test + UAT results, release recommendation
Template coming soon
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