Deviation Impact Assessment
Equipment Details
Equipment: Conductivity Meter
Area: QC Lab
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description: [Insert deviation description here]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: [Insert classification]
Product/Patient Impact
Impact Assessment: [Insert product/patient impact assessment]
Data Integrity Impact
Data Integrity Assessment: [Insert data integrity impact assessment]
Affected Batches/Studies
List of Affected Batches/Studies: [Insert affected batches/studies]
Investigation
Investigation Summary: [Insert investigation summary]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Insert CAPA details]
Re-test/Requalification Decision
Decision: [Insert re-test/requalification decision]
Quality Assurance Disposition
Disposition: [Insert QA disposition]