Deviation Impact Assessment
Equipment Information
Equipment: Stoppering Machine (Bottle Line)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter deviation description]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification]
Product/Patient Impact
Impact Description: [Enter impact description]
Data Integrity Impact
Impact Description: [Enter impact description]
Affected Batches/Studies
Batches/Studies Affected: [Enter affected batches/studies]
Investigation
Investigation Summary: [Enter investigation summary]
CAPA (Corrective and Preventive Actions)
CAPA Summary: [Enter CAPA summary]
Re-test/Requalification Decision
Decision: [Enter decision]
Rationale: [Enter rationale]
QA Disposition
Disposition: [Enter disposition]
QA Reviewer: [Enter name]
Date Reviewed: [Enter date]