Deviation Impact Assessment
Equipment Details
Equipment: Split Butterfly Valve (SBV) Transfer System
Area: Production/Containment
Criticality: Critical
Product Impact: Direct
CSV Required: No
Deviation Details
Description of Deviation: [Insert description of the deviation here]
Date of Deviation: [Insert date here]
Reported By: [Insert name here]
Classification
Classification of Deviation: [Insert classification here]
Product/Patient Impact
Impact Assessment: [Insert assessment here]
Data Integrity Impact
Assessment of Data Integrity: [Insert assessment here]
Affected Batches/Studies
Batches/Studies Affected: [Insert affected batches/studies here]
Investigation
Investigation Summary: [Insert investigation summary here]
Root Cause: [Insert root cause here]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Insert CAPA plan here]
Responsible Person: [Insert responsible person here]
Due Date: [Insert due date here]
Re-test/Requalification Decision
Decision on Re-test/Requalification: [Insert decision here]
QA Disposition
QA Disposition: [Insert QA disposition here]
Additional Comments
[Insert any additional comments here]