Transcript
A pass count is not a conclusion
Two hundred passed tests may sound reassuring, but the number does not show whether the important failures were challenged. A package can pass every scripted step and still miss an approval bypass, an interface exception, an incorrect calculation boundary, or a record-retrieval problem.
Follow risk to results
For each important GxP function, confirm the requirement, failure scenario, control, selected method, actual result, and deviation disposition. Check whether open defects, test-environment limitations, supplier changes, or untested configurations weaken the conclusion. Traceability should explain coverage, not merely count documents.
State conditions and residual risk
Approve only when the evidence supports the defined use and remaining risk is acceptable through the authorized Quality process. Record restrictions, open actions, monitoring, and reassessment criteria. The better question is not how many tests passed. It is whether the right evidence supports a well-supported release decision.