Deviation Impact Assessment
Equipment Details
Equipment: Ophthalmic Sterile Filtration Skid (0.22 µm)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter deviation description here]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification, e.g., Major/Minor]
Product/Patient Impact
Impact Assessment: [Describe impact on product/patient]
Data Integrity Impact
Data Integrity Assessment: [Describe impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Summarize investigation findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Describe proposed CAPA]
Re-test/Requalification Decision
Decision: [State re-test/requalification decision]
Quality Assurance (QA) Disposition
QA Disposition: [Enter QA disposition]