Deviation Impact Assessment
Equipment Details
Equipment: Ophthalmic Compounding Vessel (Jacketed SS)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification of Deviation: [Insert classification]
Product/Patient Impact
Potential Impact on Product: [Insert potential impact]
Potential Impact on Patient: [Insert potential impact]
Data Integrity Impact
Impact on Data Integrity: [Insert impact assessment]
Affected Batches/Studies
Affected Batches/Studies: [Insert affected batches/studies]
Investigation
Investigation Summary: [Insert investigation summary]
Investigation Lead: [Insert name]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert CAPA summary]
Responsible Person: [Insert name]
Re-Test/Requalification Decision
Re-Test/Requalification Required: [Yes/No]
Decision Summary: [Insert decision summary]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA disposition]
Reviewed By: [Insert name]
Date of Review: [Insert date]