Deviation Impact Assessment
Equipment Details
Equipment: Leak Test Machine (Bottle)
Area: Production/QC
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification]
Product/Patient Impact
Impact Assessment: [Enter assessment of product/patient impact]
Data Integrity Impact
Data Integrity Assessment: [Enter assessment of data integrity impact]
Affected Batches/Studies
List of Affected Batches/Studies: [Enter affected batches/studies]
Investigation
Investigation Summary: [Enter summary of investigation]
Investigation Findings: [Enter findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Enter summary of CAPA]
Implementation Plan: [Enter implementation plan]
Re-test/Requalification Decision
Decision: [Enter decision regarding re-test/requalification]
Rationale: [Enter rationale for decision]
Quality Assurance (QA) Disposition
Disposition: [Enter QA disposition]
Comments: [Enter any additional comments]