Automated Test Evidence Assessment

Blank template

1. Validation objective
2. Automated scope and exclusions
3. Test tool intended use and version
4. Test code and review
5. Environment and test data
6. Expected-result independence
7. Failure-detection challenge
8. Execution records and traceability
9. Failure review and rerun rules
10. Maintenance and change impact
11. Coverage limitations
12. Conclusion and approval

Completed fictional example

Fictional teaching example: This is not an executed or approved validation record.

Validation objective

Detect unauthorized CAPA closure and verify the resulting audit record

Automated scope and exclusions

Stable configured closure path; excludes unusual concurrency exploration

Test tool intended use and version

Execute approved regression and retain machine-readable result

Test code and review

Version controlled and independently reviewed

Environment and test data

Qualified test tenant with representative roles and records

Expected-result independence

Expected rejection derived from approved requirement

Failure-detection challenge

Deliberately enabled unauthorized closure causes test failure after correction

Execution records and traceability

Requirement, risk, test version, input, output, log, result, and reviewer retained

Failure review and rerun rules

Root cause and impact documented before controlled rerun

Maintenance and change impact

Application, test code, library, data, or environment change assessed

Coverage limitations

Does not replace exploratory interruption or role-administration testing

Conclusion and approval

Suitable for defined regression scope after correction