Deviation Impact Assessment Template
Equipment Details
Equipment: Labeling Machine (Bag/Bottle)
Area: Packaging/Primary
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Insert description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: [Insert classification, e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Describe potential impact on product and patients]
Data Integrity Impact
Data Integrity Assessment: [Describe potential impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide summary of investigation findings]
Corrective and Preventive Actions (CAPA)
CAPA Details: [Outline corrective and preventive actions taken]
Re-test/Requalification Decision
Decision: [State re-test or requalification decision]
Quality Assurance Disposition
QA Disposition: [Provide QA final disposition]