Deviation Impact Assessment
Equipment Information
Equipment: Ultracentrifuge
Area: R&D/Production
Criticality: Critical
Product Impact: Direct
Deviation Details
Description of Deviation: [Insert description of the deviation]
Date of Deviation: [Insert date]
Deviation Number: [Insert deviation number]
Classification
Classification: [Insert classification]
Product/Patient Impact
Impact Assessment: [Insert assessment of product/patient impact]
Data Integrity Impact
Impact Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Batches/Studies Affected: [Insert affected batches/studies]
Investigation
Investigation Details: [Insert details of the investigation]
Corrective and Preventive Actions (CAPA)
CAPA Details: [Insert CAPA details]
Re-test/Requalification Decision
Decision: [Insert re-test/requalification decision]
Quality Assurance (QA) Disposition
Disposition: [Insert QA disposition]