CSV Deviation Report
validation deviation · test script deviation
A controlled record of any failed test script, unexpected result, or scope deviation during computerised system validation, with impact assessment and resolution before release.
During IQ/OQ/PQ execution, any unexpected result, failed step, or scope change is captured as a validation deviation. The report documents the deviation, root cause, impact on the validated state, corrective actions, and the re-test evidence. Validation cannot close until every deviation is resolved or accepted with documented justification.
V5 links validation deviations to the originating test script and to post-go-live change controls so the validation history of every release is auditable.
- GAMP 5 (2nd Ed.)
- EU GMP Annex 11
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