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bio
vivo
SCIENCE
Quality Record
Deviation & CAPA Report
Document any departure from procedure or specification, and the corrective action taken
Deviation No.
Date Identified
Reported By
Batch / Lot
Area / Process Stage
Product
Severity
Minor
Major
Critical
Product Impact?
No impact
Possible impact — under review
Confirmed impact
1 · Description of Deviation
2 · Immediate Action Taken
3 · Root Cause Analysis
4 · Corrective & Preventive Action (CAPA)
5 · Disposition of Affected Material
QA Approved By
Date Closed
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