Deviation Impact Assessment
Equipment Details
Equipment: Vacuum Degassing System
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert details of the deviation]
Date of Deviation: [Insert date]
Classification
Classification of Deviation: [Insert classification, e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Insert assessment of product/patient impact]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [Insert affected batches or studies]
Investigation
Investigation Summary: [Insert summary of investigation]
Corrective and Preventive Action (CAPA)
CAPA Plan: [Insert CAPA plan details]
Re-test/Requalification Decision
Decision: [Insert decision on re-test/requalification]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA disposition]