# AI validation summary

Version 2.0 · Updated 2026-09-21 · Release

Reconcile the evidence, failures and operating restrictions into an assessable release decision.

Adapt this template to your intended use, applicable requirements, and approved procedures.

## When to use it

Use when you need to reconcile the evidence, failures and operating restrictions into an assessable release decision.

## Information needed before starting

- Defined AI use, authority limits and assessed configuration
- Controlled sources and independent reference results relevant to this worksheet
- Applicable risk assessment, acceptance basis and responsible reviewers

## 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 |

## Related guidance

- [Read chapter 7: AI Validation Evidence Plan](https://csvtocsa.com/ai-assurance-academy/ai-in-csv-csa-chapter-7-data-governance-provenance-and-alcoa-for-ai)

- [Read chapter 20: AI Release Decision: Complete Case Study](https://csvtocsa.com/ai-assurance-academy/ai-in-csv-csa-chapter-20-end-to-end-case-study-and-inspection-readiness)

Canonical page: https://csvtocsa.com/worksheets/ai-validation-summary