Deviation Impact Assessment Template
Equipment Details
Equipment: Coding/Printing Machine (Inkjet/Laser)
Area: Packaging/Primary
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification]
Product/Patient Impact
Impact Assessment: [Enter assessment details]
Data Integrity Impact
Data Integrity Assessment: [Enter assessment details]
Affected Batches/Studies
Affected Batches/Studies: [Enter batch/study numbers]
Investigation
Investigation Summary: [Enter summary of investigation]
Investigation Lead: [Enter name]
Investigation Date: [Enter date]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Enter summary of CAPA]
Responsible Person: [Enter name]
Due Date: [Enter due date]
Re-test/Requalification Decision
Decision: [Enter decision]
Re-test/Requalification Date: [Enter date]
Quality Assurance Disposition
QA Disposition: [Enter disposition]
QA Approval Date: [Enter date]