Deviation Impact Assessment
Equipment Information
Equipment: Serialization System
Area: Packaging
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Enter detailed description of the deviation]
Date of Occurrence: [Enter date]
Classification
Classification of Deviation: [Enter 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 the impact on data integrity]
Affected Batches/Studies
Affected Batches: [List affected batches]
Affected Studies: [List affected studies]
Investigation
Investigation Summary: [Provide a summary of the investigation conducted]
Findings: [List findings from the investigation]
Corrective and Preventive Actions (CAPA)
Actions Taken: [Describe actions taken to address the deviation]
Preventive Measures: [Describe measures to prevent recurrence]
Re-test/Requalification Decision
Decision: [State the decision regarding re-test or requalification]
Rationale: [Provide rationale for the decision]
Quality Assurance (QA) Disposition
Disposition: [State the QA disposition]
Comments: [Provide any additional comments]