Deviation Impact Assessment
Equipment Information
Equipment: Inline Conductivity Meter
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Classification
Classification Level: [Insert classification level]
Product/Patient Impact
Impact Assessment: [Insert assessment of potential product/patient impact]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Insert summary of the investigation conducted]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert summary of corrective and preventive actions]
Re-Test/Requalification Decision
Decision: [Insert decision regarding re-test/requalification]
Quality Assurance (QA) Disposition
Disposition: [Insert QA disposition]