Deviation Impact Assessment
Equipment Details
Equipment: Bin Dryer (IBC Dryer)
Area: Production/Drying
Criticality: Major
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Classification
Classification of Deviation: [Insert classification]
Product/Patient Impact
Impact Assessment: [Insert assessment of product/patient impact]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [Insert affected batches or studies]
Investigation
Investigation Summary: [Insert summary of the investigation conducted]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Insert CAPA plan details]
Re-test/Requalification Decision
Decision: [Insert decision on re-test/requalification]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA disposition]