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