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Two facilities. Same contract manufacturer. Same product line. Same atypical viscosity result — within specification, exception noted, review required before release. Both QPs reviewed the exception. Both concluded the batch met release criteria. Both signed. One walked out of inspection with no observations. The other received a 483. The difference was not in what either QP concluded. The difference was in what existed in each file after the decision was made.
Read the full case →The difference wasn't in what either QP concluded. The difference was in what existed in each file after the decision was made.
A closed CAPA with no effectiveness authorization record cannot be defended when the root cause recurs.
The investigation was complete. The result was explained. But when the investigator asked who authorized the OOS conclusion — there was no record.
When the investigator asked about your last release decision — what existed in the file beyond the signature?
The last time a CAPA was closed in your system — what evidence existed that the effectiveness determination was formally authorized?
Your last OOS result that was invalidated — what record exists showing who authorized that conclusion and what evidence they reviewed?
Authorization gaps. 483 patterns. Decision trail failures. Delivered to compliance professionals who want to walk into the inspection room prepared.
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