Deviation Impact Assessment
Equipment Details
Equipment: Automated Visual Inspection Machine
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Insert description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification: [Insert classification]
Product/Patient Impact
Impact Assessment: [Insert assessment of product/patient impact]
Data Integrity Impact
Impact Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Batches/Studies Affected: [Insert affected batches/studies]
Investigation
Investigation Summary: [Insert summary of the investigation]
CAPA
Corrective and Preventive Actions: [Insert CAPA details]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test/requalification]
QA Disposition
Disposition: [Insert QA disposition]