Deviation Impact Assessment Template
Equipment Information
Equipment: Weighing Balance (Platform/Floor)
Area: Production/Dispensing
Criticality: Major
Product Impact: Direct
Deviation Details
Description of Deviation: [Insert description of the deviation]
Date of Deviation: [Insert date]
Classification
Deviation Classification: [Insert classification]
Product/Patient Impact
Impact Assessment: [Insert assessment of product/patient impact]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [Insert list of affected batches/studies]
Investigation
Investigation Summary: [Insert summary of investigation]
Corrective Action and Preventive Action (CAPA)
CAPA Summary: [Insert summary of CAPA]
Re-test/Requalification Decision
Decision: [Insert re-test/requalification decision]
Quality Assurance (QA) Disposition
Disposition: [Insert QA disposition]