Deviation Impact Assessment
Equipment Details
Equipment: Double Cone Blender
Area: Production/Blending
Criticality: Major
Product Impact: Direct
Deviation Details
Deviation Description: [Insert deviation description here]
Date of Deviation: [Insert date here]
Deviation Classification
Classification: [Insert classification here]
Product/Patient Impact
Impact Assessment: [Insert impact assessment here]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment here]
Affected Batches/Studies
Batches/Studies Affected: [Insert affected batches/studies here]
Investigation
Investigation Summary: [Insert investigation summary here]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert CAPA summary here]
Re-test/Requalification Decision
Decision: [Insert decision here]
QA Disposition
Disposition: [Insert QA disposition here]