Deviation Impact Assessment Template
Equipment Details
Equipment: Biosafety Cabinet (Class II/III)
Area: Production/Cell Culture
Criticality: Critical
Product Impact: Direct
CSV Required: No
Deviation Details
Description of Deviation: [Enter details of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification, e.g., Minor, Major, Critical]
Product/Patient Impact
Impact Assessment: [Describe the potential impact on product and patient]
Data Integrity Impact
Data Integrity Assessment: [Describe any impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide details of the investigation conducted]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Outline corrective and preventive actions taken]
Re-test/Requalification Decision
Decision on Re-test/Requalification: [State the decision and rationale]
Quality Assurance Disposition
QA Disposition: [Provide the final disposition from QA]