Deviation Impact Assessment Template
Equipment Details
Equipment: Vacuum Tray Dryer
Area: Production/Drying
Criticality: Major
Product Impact: Direct
CSV Required: No
Deviation Details
Deviation Description: [Provide a detailed description of the deviation]
Date of Deviation: [Insert date]
Classification
Deviation Classification: [Classify the deviation, e.g., Major, Minor, etc.]
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
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Summarize the investigation process and findings]
Corrective and Preventive Actions (CAPA)
CAPA Description: [Detail the corrective and preventive actions taken]
Re-test/Requalification Decision
Decision: [State the decision regarding re-testing or re-qualification]
Quality Assurance (QA) Disposition
QA Disposition: [Provide the final QA disposition regarding the deviation]