Deviation Impact Assessment
Equipment Details
Equipment: Capping Machine (ROPP/Screw)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Classification
Classification: [Enter classification, e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Describe the potential impact on product and patient]
Data Integrity Impact
Data Integrity Assessment: [Describe the impact on data integrity]
Affected Batches/Studies
Batches/Studies Affected: [List affected batches or studies]
Investigation
Investigation Summary: [Summarize the investigation process and findings]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Detail the CAPA actions to be taken]
Re-test/Requalification Decision
Decision: [State the decision regarding re-testing or requalification]
Quality Assurance Disposition
QA Disposition: [Enter QA’s final disposition on the deviation]