Deviation Impact Assessment
Equipment Details
Equipment: Suppository Leak Test Machine
Area: Production/QC
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: [Insert classification]
Product/Patient Impact
Impact Assessment: [Insert impact assessment details]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment details]
Affected Batches/Studies
Affected Batches: [Insert batch numbers or study identifiers]
Investigation
Investigation Summary: [Insert summary of investigation findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert CAPA details]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test or requalification]
QA Disposition
Disposition Summary: [Insert QA disposition details]