Deviation Impact Assessment Template
Equipment Information
Equipment: Lipid Melting / Lipid Preparation Vessel (Jacketed SS/Glass)
Area: R&D/Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter deviation description here]
Date of Deviation: [Enter date here]
Reported By: [Enter name here]
Classification
Classification: [Enter classification here]
Product/Patient Impact
Impact Assessment: [Enter assessment here]
Data Integrity Impact
Data Integrity Assessment: [Enter assessment here]
Affected Batches/Studies
Batches/Studies Affected: [Enter affected batches/studies here]
Investigation
Investigation Summary: [Enter investigation summary here]
Corrective and Preventive Action (CAPA)
CAPA Summary: [Enter CAPA summary here]
Re-test/Requalification Decision
Decision: [Enter decision here]
Quality Assurance (QA) Disposition
Disposition: [Enter QA disposition here]