Deviation Impact Assessment Template
Deviation Details
Equipment: Weighing Balance (Analytical)
Area: Production/Dispensing
Criticality: Critical
Product Impact: Direct
CSV Required: No
Deviation Classification
Please classify the deviation:
- Minor
- Major
- Critical
Product/Patient Impact
Describe the potential impact on product quality and patient safety:
Data Integrity Impact
Assess the impact on data integrity:
Affected Batches/Studies
List any affected batches or studies:
Investigation
Provide details of the investigation conducted:
Corrective and Preventive Actions (CAPA)
Outline the CAPA taken in response to the deviation:
Re-test/Requalification Decision
State the decision regarding re-testing or re-qualification:
Quality Assurance (QA) Disposition
Document the QA disposition regarding the deviation: