AI validation summary
Reconcile the evidence, failures and operating restrictions into an assessable release decision.
Adapt this worksheet to your applicable procedures, intended use and requirements. Fictional examples are teaching material, not execution evidence.
Field instructions
- Use and configuration: Identify the exact proposed use, users and evaluated configuration.
- Applicable scope: Link the local GxP, record and jurisdiction assessment.
- Evidence reviewed: List requirements, risks, supplier evidence, tests and reviewer evaluation.
- Acceptance results: Report successes and failures by their stated criteria.
- Traceability: Link each relevant requirement/risk to evidence and deviation disposition.
- Open issues: State the impact of each unresolved deviation or dependency.
- Conclusion and restrictions: Describe what is permitted, withheld or excluded, and why.
- Operational readiness: Identify record, monitoring, incident, change and periodic-review arrangements.
- Approval responsibility: Identify required local approval roles; do not invent a signature.
- Reconsideration triggers: State the additional evidence needed before changing the decision.
Completed fictional example
Fictional VSR-01 records a withheld expansion, not a successful production validation.
| Decision item | Completed example |
|---|---|
| Configuration | PRA-01 v0.8 / M-2026-09-eval / P-03 / PAR-02 / RET-04 |
| Evidence | IU-01, SYS-01, GXP-01, SUP-01, TP-01, HR-01 and RTM-01 |
| Failed criteria | Two AI critical misses; one final assisted critical miss; two false findings accepted |
| Other checks | 6/6 permission, 12/12 record-package and 4/4 failure/recovery checks pass within planned scope |
| Open issues | DEV-01/02/03 and SUP-G01 remain open |
| Conclusion | Expanded production reliance not approved; restricted evaluation may continue only within its authorized boundary |
| Required evidence | Correct causes; evaluate fresh protected cases and representative users; resolve material supplier and operational gaps |
Blank worksheet
System / record ID: ____________________
Prepared by / date: ____________________
Required review / approval under local procedure: ____________________
| Field | Your entry |
|---|---|
| Use and configuration | ____________________ |
| Applicable scope | ____________________ |
| Evidence reviewed | ____________________ |
| Acceptance results | ____________________ |
| Traceability | ____________________ |
| Open issues | ____________________ |
| Conclusion and restrictions | ____________________ |
| Operational readiness | ____________________ |
| Approval responsibility | ____________________ |
| Reconsideration triggers | ____________________ |
Blank results or assessment rows
| Decision item | Completed example |
|---|---|
| ____________________ | ____________________ |
| ____________________ | ____________________ |
| ____________________ | ____________________ |