Deviation Impact Assessment
Equipment Details
Equipment: Aseptic Filling Machine (IV Bags)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation ID: [Enter Deviation ID]
Description: [Enter Deviation Description]
Date of Deviation: [Enter Date]
Classification
Classification: [Enter Classification, e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Enter Impact Assessment]
Data Integrity Impact
Data Integrity Assessment: [Enter Data Integrity Assessment]
Affected Batches/Studies
Affected Batches: [Enter Affected Batches]
Affected Studies: [Enter Affected Studies]
Investigation
Investigation Summary: [Enter Investigation Summary]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Enter CAPA Summary]
Re-test/Requalification Decision
Decision: [Enter Decision]
Rationale: [Enter Rationale]
Quality Assurance Disposition
Disposition: [Enter Disposition]
Reviewer: [Enter Reviewer Name]
Date of Review: [Enter Date]