Deviation Impact Assessment Template
Equipment: Tangential Flow Filtration (TFF) System
Area: R&D/Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Type: [Insert classification type, e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Insert assessment of product/patient impact]
Data Integrity Impact
Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Batches/Studies Affected: [Insert affected batches/studies]
Investigation
Investigation Details: [Insert details of the investigation conducted]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Insert details of the CAPA plan]
Re-Test/Requalification Decision
Decision: [Insert decision regarding re-test/requalification]
QA Disposition
Disposition: [Insert QA disposition]
Approval
Prepared By: [Insert name]
Reviewed By: [Insert name]
Approval Date: [Insert date]