Deviation Impact Assessment
Equipment Details
Equipment: Leak Test Machine (CCIT)
Area: Production/QC
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert description]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: [Insert classification]
Product/Patient Impact
Impact Assessment: [Insert assessment]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment]
Affected Batches/Studies
Affected Batches/Studies: [Insert batches/studies]
Investigation
Investigation Summary: [Insert summary]
Root Cause: [Insert root cause]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert summary]
Responsible Person: [Insert name]
Due Date: [Insert due date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details: [Insert details]
QA Disposition
Disposition Summary: [Insert summary]
Reviewed By: [Insert name]
Date of Review: [Insert date]