Deviation Impact Assessment
Equipment Details
Equipment: Vent Filter Assembly
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: No
Deviation Details
Deviation Description: [Enter deviation details here]
Classification: [Enter classification here]
Impact Assessment
Product/Patient Impact: [Enter product/patient impact here]
Data Integrity Impact: [Enter data integrity impact here]
Affected Batches/Studies: [Enter affected batches/studies here]
Investigation
Investigation Summary: [Enter investigation details here]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Enter CAPA details here]
Re-test/Requalification Decision
Decision: [Enter re-test/requalification decision here]
Quality Assurance (QA) Disposition
Disposition: [Enter QA disposition here]