Deviation Impact Assessment
Equipment Details
Equipment: Pouch Sealing Machine
Area: Packaging
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification: [Insert classification, e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Insert assessment of potential impact on product and 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 investigation conducted]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Insert CAPA details]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test or requalification]
Quality Assurance Disposition
Disposition: [Insert QA disposition outcome]