Deviation Impact Assessment
Equipment Details
Equipment: Dispensing Booth (Downflow)
Area: Production/Dispensing
Criticality: Critical
Product Impact: Direct
CSV Required: No
Deviation Details
Deviation Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification: [Insert classification, e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Insert assessment of potential impact on product and patient]
Data Integrity Impact
Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Batches/Studies Affected: [List affected batches or studies]
Investigation
Investigation Summary: [Insert summary of investigation findings]
Root Cause: [Insert identified root cause]
CAPA (Corrective and Preventive Action)
CAPA Description: [Insert description of corrective and preventive actions]
Responsible Person: [Insert name]
Due Date: [Insert due date]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test or requalification]
QA Disposition
Disposition: [Insert QA disposition]
Reviewed By: [Insert name]
Date of Review: [Insert date]