Deviation Impact Assessment Template
Equipment Details
Equipment: Pouch Packaging & Seal Integrity Tester
Area: Packaging
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification, e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Describe potential impact on product and patient]
Data Integrity Impact
Data Integrity Assessment: [Describe impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Summarize investigation findings]
CAPA (Corrective and Preventive Action)
CAPA Summary: [Describe actions taken to resolve the deviation]
Re-Test/Requalification Decision
Decision: [State re-test/requalification decision]
QA Disposition
QA Disposition: [Enter QA disposition]
Attachments
CSV Documentation: [Attach required CSV documentation]