Deviation Impact Assessment Template
Equipment Details
Equipment: LAF Workstation / Grade A Bench
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: No
Deviation Details
Description of Deviation: [Enter deviation description]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Classification of Deviation: [Enter classification]
Product/Patient Impact
Impact Assessment: [Enter impact assessment]
Data Integrity Impact
Data Integrity Assessment: [Enter data integrity assessment]
Affected Batches/Studies
Affected Batches/Studies: [Enter affected batches/studies]
Investigation
Investigation Summary: [Enter investigation summary]
Root Cause Analysis: [Enter root cause]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Enter CAPA plan]
Responsible Person: [Enter responsible person]
Due Date: [Enter due date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details of Re-test/Requalification: [Enter details]
QA Disposition
QA Review Date: [Enter review date]
Disposition: [Enter QA disposition]