Deviation Impact Assessment
Equipment Details
Equipment: Fluid Bed Dryer (FBD)
Area: Production/Drying
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter deviation description here]
Date of Deviation: [Enter date here]
Reported By: [Enter name here]
Classification
Classification: [Enter classification here]
Product/Patient Impact
Impact Assessment: [Enter assessment here]
Data Integrity Impact
Data Integrity Assessment: [Enter assessment here]
Affected Batches/Studies
Affected Batches/Studies: [Enter affected batches/studies here]
Investigation
Investigation Details: [Enter investigation details here]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Enter CAPA plan here]
Re-test/Requalification Decision
Decision: [Enter decision here]
Quality Assurance (QA) Disposition
Disposition: [Enter QA disposition here]
Signatures
Prepared By: [Enter name here]
Date: [Enter date here]
Approved By: [Enter name here]
Date: [Enter date here]