Deviation Impact Assessment Template
Equipment Details
Equipment: Vial Washing 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
Deviation Classification: [Insert classification, e.g., Major/Minor]
Product/Patient Impact
Impact on Product: [Insert details]
Impact on Patient: [Insert details]
Data Integrity Impact
Impact on Data Integrity: [Insert details]
Affected Batches/Studies
Affected Batches/Studies: [Insert batch/study numbers]
Investigation
Investigation Details: [Insert investigation findings]
Corrective and Preventive Actions (CAPA)
CAPA Details: [Insert CAPA actions]
Re-test/Requalification Decision
Re-test/Requalification Decision: [Insert decision]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA disposition]