Deviation Impact Assessment Template
Equipment Details
Equipment: Cold Room (2–8°C)
Area: Warehouse
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter deviation description here]
Date of Deviation: [Enter date]
Classification
Deviation Classification: [Enter classification, e.g., Major/Minor]
Product/Patient Impact
Impact Assessment: [Describe the potential impact on product and patients]
Data Integrity Impact
Data Integrity Assessment: [Describe the impact on data integrity]
Affected Batches/Studies
Affected Batches: [List affected batches]
Affected Studies: [List affected studies]
Investigation
Investigation Summary: [Provide a summary of the investigation conducted]
CAPA (Corrective and Preventive Actions)
CAPA Summary: [Outline the CAPA plan]
Re-test/Requalification Decision
Decision: [State the re-test/requalification decision]
QA Disposition
QA Disposition: [Provide QA’s final disposition]