Deviation Impact Assessment
Equipment Information
Equipment: Ophthalmic Bottle Washing Machine
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description: [Insert deviation description here]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Type: [Insert classification type]
Severity: [Insert severity level]
Product/Patient Impact
Impact Assessment: [Insert impact assessment]
Data Integrity Impact
Assessment: [Insert data integrity assessment]
Affected Batches/Studies
Batches/Studies Affected: [Insert batch/study information]
Investigation
Investigation Initiation Date: [Insert date]
Investigation Findings: [Insert findings]
Corrective and Preventive Actions (CAPA)
Actions Taken: [Insert actions]
Responsible Person: [Insert name]
Due Date: [Insert date]
Re-test/Requalification Decision
Decision: [Insert decision]
Re-test/Requalification Date: [Insert date]
Quality Assurance Disposition
Disposition Status: [Insert status]
QA Comments: [Insert comments]