Deviation Impact Assessment
Equipment Information
Equipment: High Pressure Homogenizer / Microfluidizer
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 Description: [Enter product/patient impact description here]
Data Integrity Impact
Impact Description: [Enter data integrity impact description here]
Affected Batches/Studies
Batches/Studies Affected: [Enter affected batches/studies here]
Investigation
Investigation Summary: [Enter investigation summary here]
Investigation Lead: [Enter name here]
Corrective and Preventive Actions (CAPA)
CAPA Description: [Enter CAPA description here]
Responsible Person: [Enter name here]
Due Date: [Enter due date here]
Re-test/Requalification Decision
Decision: [Enter re-test/requalification decision here]
Rationale: [Enter rationale here]
Quality Assurance (QA) Disposition
Disposition: [Enter QA disposition here]
Reviewed By: [Enter name here]
Date of Review: [Enter date here]