Deviation Impact Assessment
Equipment Information
Equipment: Terminal HEPA Filters
Area: Engineering
Criticality: Critical
Product Impact: Direct
CSV Required: No
Deviation Details
Description of Deviation: [Enter details of the deviation here]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification]
Product/Patient Impact
Potential Impact on Product: [Describe impact]
Potential Impact on Patient: [Describe impact]
Data Integrity Impact
Impact on Data Integrity: [Describe impact]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Summarize investigation findings]
Investigation Lead: [Enter name]
Investigation Date: [Enter date]
CAPA (Corrective and Preventive Actions)
Proposed CAPA: [List proposed actions]
Responsible Person: [Enter name]
Due Date: [Enter date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details: [Provide details]
QA Disposition
QA Disposition: [Enter disposition]
Disposition Date: [Enter date]