Run IQ, OQ and PQ from the floor — with evidence and deviations attached.

Execution is where the paperwork falls apart

Testing is usually done well. Recording it is where the findings come from: screenshots that cannot be attributed to who captured them, evidence pasted into a document days later, a witness signature added retrospectively because nobody was available on the day.

The most damaging version is the protocol approved after it was executed. It is immediately visible from the dates, it is one of the fastest findings an inspector can write, and it almost always happens because of schedule pressure rather than intent.

A gate before anything runs

Execution is refused until the validation plan, the requirements and the protocol itself are approved and the case is marked ready. The order is enforced rather than recommended, which removes the most common finding in this area by making it impossible rather than discouraged.

Evidence captured in the moment

Verdicts are recorded step by step as the work happens, with evidence attached at the point of capture and sealed so it can be shown to be the file that was taken at the time. The executor is recorded, and where a second person is required their witness signature is captured as part of the record rather than collected afterwards.

A person cannot witness their own execution. That is enforced, not left to the honesty of whoever is filling in the form at the end of a long day.

Failures become deviations, not notes

A failed step raises a deviation automatically and links it to the case, the requirement and the record. The deviation runs its own investigation and resolution, and where a CAPA is needed its effectiveness is tracked before the re-execution closes the loop.

Re-test attempts are recorded as attempts. The history of what failed, why, and what changed before it passed stays visible — which is the question an auditor asks when a test passes on the third attempt.