Deviation Impact Assessment
Equipment Information
Equipment: Inline Particle Size Analyzer (PAT)
Area: Instrument
Criticality: Direct
Product Impact: PAT monitoring of particle size
CSV Required: Yes
Deviation Details
Description: [Insert deviation description here]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Deviation Classification
Classification: [Insert classification here]
Product/Patient Impact
Impact Assessment: [Insert impact assessment here]
Data Integrity Impact
Assessment: [Insert data integrity assessment here]
Affected Batches/Studies
Batches/Studies Affected: [Insert affected batches/studies here]
Investigation
Investigation Summary: [Insert investigation summary here]
CAPA (Corrective and Preventive Action)
CAPA Summary: [Insert CAPA summary here]
Re-test/Requalification Decision
Decision: [Insert re-test/requalification decision here]
QA Disposition
Disposition: [Insert QA disposition here]