Deviations
Explain the expected and actual result, affected requirement, impact, correction and retest. Resolve or formally assess open issues and define any restrictions. A large pass count does not cancel a critical failure.
Traceability
Connect important requirements and risks to the evidence that demonstrates them. Identify missing coverage, changed requirements and tests that no longer support the current configuration.
Validation summary
Summarize the intended use, version, work performed, results, deviations, limitations and remaining risk. Reference the underlying controlled evidence.
Release decision
The authorized people decide whether the evidence supports the specified use. Record the decision, conditions, responsibilities and any follow-up. A tool-generated summary is not an approval.
Fictional example. Two hundred tests pass, but three unresolved failures affect product acceptance. Assess those failures and restrict the affected use; the overall pass rate does not establish readiness.
Practitioner guidance by Sandip Thorat · Simplified 17 September 2026. Apply the requirements and approved procedures relevant to your system. Report a correction.