Deviation Impact Assessment
Equipment Details
Equipment: Tray Dryer
Area: Production/Drying
Criticality: Major
Product Impact: Direct
Deviation Details
Deviation Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Classification
Classification: Major
Product/Patient Impact
Impact Assessment: [Describe potential impact on product quality and patient safety]
Data Integrity Impact
Assessment: [Evaluate any impact on data integrity]
Affected Batches/Studies
Affected Batches: [List affected batches or studies]
Investigation
Investigation Summary: [Provide a summary of the investigation conducted]
CAPA (Corrective and Preventive Actions)
Actions Taken: [Detail the corrective and preventive actions implemented]
Re-test/Requalification Decision
Decision: [State whether re-testing or re-qualification is required]
QA Disposition
Disposition Status: [Provide QA’s final disposition on the affected batches]