Deviation Impact Assessment
Equipment Information
Equipment: Cartridge Stoppering Machine
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: [Insert classification, e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Describe the impact on product quality and patient safety]
Data Integrity Impact
Data Integrity Assessment: [Evaluate the impact on data integrity]
Affected Batches/Studies
List of Affected Batches/Studies:
- [Batch/Study 1]
- [Batch/Study 2]
- [Batch/Study 3]
Investigation
Investigation Summary: [Provide a summary of the investigation conducted]
Findings: [List key findings from the investigation]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Outline the CAPA plan developed to address the deviation]
Re-Test/Requalification Decision
Decision: [State whether re-testing or re-qualification is required]
Rationale: [Provide rationale for the decision]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA disposition decision]
Comments: [Insert any additional comments from QA]