Deviation Impact Assessment Template
Equipment Details
Equipment: Solution Preparation Tank
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification: [Insert classification level, e.g., Major/Minor]
Product/Patient Impact
Impact Assessment: [Describe potential impact on product and patient]
Data Integrity Impact
Data Integrity Assessment: [Describe impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide a summary of the investigation conducted]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Detail the CAPA plan]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test or requalification]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA decision]