Deviation Impact Assessment
Equipment Details
Equipment: In-vitro Release Testing System (Dialysis/Flow-through/USP apparatus as applicable)
Area: QC/R&D
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter details of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification, e.g., Major/Minor]
Product/Patient Impact
Impact Description: [Describe the impact on product/patient]
Data Integrity Impact
Impact Description: [Describe the impact on data integrity]
Affected Batches/Studies
Batches/Studies Affected: [List affected batches/studies]
Investigation
Investigation Summary: [Summarize the investigation process]
Root Cause Analysis: [Enter root cause]
Corrective and Preventive Action (CAPA)
CAPA Description: [Describe the CAPA plan]
Responsible Person: [Enter name]
Due Date: [Enter due date]
Re-test/Requalification Decision
Decision Summary: [Enter re-test/requalification decision]
Quality Assurance (QA) Disposition
QA Disposition: [Enter QA disposition]
Reviewed By: [Enter name]
Date of Review: [Enter date]