Deviation Impact Assessment
Equipment Details
Equipment: Prefilled Syringe Washing Machine
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, e.g., Major, Minor]
Product/Patient Impact
Impact on Product: [Describe the impact on the product]
Impact on Patient: [Describe the impact on patient safety]
Data Integrity Impact
Impact on Data Integrity: [Describe any impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide a summary of the investigation conducted]
Investigation Findings: [Detail the findings from the investigation]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Describe the corrective and preventive actions proposed]
Re-Test/Requalification Decision
Decision: [State the decision regarding re-test or requalification]
Rationale: [Provide rationale for the decision]
Quality Assurance (QA) Disposition
QA Disposition: [State the QA disposition of the deviation]
Comments: [Any additional comments from QA]