Deviation Impact Assessment
Equipment Information
Equipment: Sterile Powder Filling Machine
Area: Production
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
Classification Level: [Insert classification level]
Product/Patient Impact
Impact Assessment: [Insert assessment of product/patient impact]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches: [Insert batch numbers]
Affected Studies: [Insert study names]
Investigation
Investigation Summary: [Insert summary of investigation]
Root Cause Analysis: [Insert root cause analysis]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Insert CAPA plan]
Implementation Timeline: [Insert timeline]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test/requalification]
Rationale: [Insert rationale for decision]
Quality Assurance Disposition
QA Disposition: [Insert QA disposition]
Comments: [Insert any additional comments]