Deviation Impact Assessment
Equipment: Solvent Recovery System
Area: Production
Criticality: Critical
Product Impact: Indirect
CSV Required: Yes
Deviation Details
[Provide a detailed description of the deviation, including date, nature of the deviation, and any relevant observations.]
Classification
[Classify the deviation according to internal procedures, e.g., Major, Minor, Critical.]
Product/Patient Impact
[Assess the potential impact on the product and/or patient safety.]
Data Integrity Impact
[Evaluate any implications for data integrity as a result of the deviation.]
Affected Batches/Studies
[List all affected batches or studies related to the deviation.]
Investigation
[Outline the investigation process undertaken, including findings and root cause analysis.]
CAPA (Corrective and Preventive Action)
[Detail the CAPA plan, including actions taken to address the deviation and prevent recurrence.]
Re-test/Requalification Decision
[Document the decision regarding the need for re-testing or re-qualification of the affected equipment.]
QA Disposition
[Include the Quality Assurance disposition regarding the affected product and any necessary actions.]