Pre-screen executed batch records against the approved master record and specification limits, flagging likely deviations and missing signatures, so QA review starts from a shorter list.
QA reviewers manually re-check every field on every batch record against spec before release, and inconsistencies found late in the cycle delay lot disposition.
That line-by-line review is repetitive even though the final release decision needs real judgment.
against approved master batch record and specification limits
Qualified Person release sign-off
A pre-screened batch record for a released product lot came back with one out-of-specification result on a dissolution test and a missing operator signature on the cleaning-verification step, ahead of the Qualified Person's release decision.
Try it — same review surface your operators use, with a representative decision. Nothing here is saved or sent anywhere.
The final release decision stays with your Qualified Person and QA team, along with judgment on any in-process deviation or out-of-specification result the system flags.
See this workflow against your own queue.
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