The Authorization Record is where QA Directors, VP Quality, and Regulatory Affairs professionals who understand what FDA investigators actually ask — and why most organizations cannot answer — come to think, discuss, and prepare.
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 →A closed CAPA with no effectiveness authorization record cannot be defended when the root cause recurs. The investigator's question goes directly to whether an effectiveness determination was actually made.
OOS InvestigationThe investigation was complete. The laboratory data passed. The result was explained. But when the investigator asked who authorized the OOS conclusion — and under what evidentiary standard — there was no record.
DeviationThe investigator doesn't open your deviation report. He opens a different question. Who authorized the continuation decision — and what evidence did they have at the time?
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