Deviation Impact Assessment
Equipment Details
Equipment: Ultrasonicator (Probe/Bath)
Area: R&D/Production
Criticality: Major
Product Impact: Direct
CSV Required: No
Deviation Details
Deviation Description: [Enter detailed description of the deviation]
Date of Occurrence: [Enter date]
Reported By: [Enter name]
Classification
Classification: Major
Product/Patient Impact
Impact Assessment: [Describe the potential 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]
Corrective and Preventive Actions (CAPA)
CAPA Actions: [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 QA’s decision on the deviation]