Deviation Impact Assessment
Equipment Information
Equipment: Tablet Deduster
Area: Production/Compression
Criticality: Major
Product Impact: Direct
CSV Required: No
Deviation Details
Deviation Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Classification
Deviation Classification: [Insert classification]
Product/Patient Impact
Impact Description: [Insert description of how the deviation impacts the product and/or patient]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [Insert list of affected batches or studies]
Investigation
Investigation Summary: [Insert summary of the investigation conducted]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert summary of corrective and preventive actions taken]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test or requalification]
Quality Assurance Disposition
QA Disposition: [Insert QA disposition]