Deviation Impact Assessment Template
Equipment Details
Equipment: Nano Tracking Analysis (NTA) System
Area: QC/R&D
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification (e.g., Major, Minor)]
Product/Patient Impact
Impact Assessment: [Describe the impact on product and patient]
Data Integrity Impact
Data Integrity Assessment: [Describe the impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide a summary of the investigation]
CAPA (Corrective and Preventive Actions)
CAPA Plan: [Outline the CAPA plan]
Re-test/Requalification Decision
Decision: [State the decision regarding re-test/requalification]
QA Disposition
QA Disposition: [Enter QA disposition]