Batch Release
When the investigator asked about your last release decision — what existed in the file beyond the signature?
CAPA
The last time a CAPA was closed in your system — what evidence existed that the effectiveness determination was formally authorized?
OOS
In your facility, when an OOS result is invalidated — what record exists of who made that authorization and what evidence they reviewed?
Deviation
When your last deviation required a continuation decision — who made it, and where is that authorization recorded?
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