Deviation Impact Assessment
Equipment Details
Equipment: Ophthalmic Holding Tank (Sterile/Pressurized)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description: [Enter deviation description]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Type: [Enter classification type]
Product/Patient Impact
Impact Assessment: [Enter assessment details]
Data Integrity Impact
Assessment: [Enter data integrity impact details]
Affected Batches/Studies
Batches/Studies Affected: [Enter affected batches/studies]
Investigation
Investigation Summary: [Enter investigation summary]
Findings: [Enter findings]
Corrective and Preventive Action (CAPA)
CAPA Plan: [Enter CAPA details]
Re-test/Requalification Decision
Decision: [Enter decision]
QA Disposition
Disposition: [Enter QA disposition]