Deviation Impact Assessment Template
Equipment Details
Equipment: Lyophilizer
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Enter details here]
Date of Deviation: [Enter date here]
Deviation Number: [Enter number here]
Classification
Classification of Deviation: [Enter classification here]
Product/Patient Impact
Impact on Product: [Enter impact details here]
Impact on Patient: [Enter patient impact details here]
Data Integrity Impact
Impact on Data Integrity: [Enter data integrity impact here]
Affected Batches/Studies
Batch/Study Numbers: [Enter affected batches/studies here]
Investigation
Investigation Summary: [Enter investigation summary here]
Investigation Team: [Enter team members here]
Corrective and Preventive Action (CAPA)
CAPA Plan: [Enter CAPA plan here]
Responsible Person: [Enter responsible person here]
Due Date: [Enter due date here]
Re-Test/Requalification Decision
Re-Test Required: [Yes/No]
Requalification Required: [Yes/No]
Decision Summary: [Enter decision summary here]
Quality Assurance (QA) Disposition
QA Disposition: [Enter disposition here]
Disposition Date: [Enter date here]