Deviation Impact Assessment
Equipment: Microneedle Mold Filling / Casting System
Area: R&D/Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Please provide a detailed description of the deviation:
Classification
Select the classification of the deviation:
Major
Minor
Critical
Product/Patient Impact
Describe the potential impact on the product and/or patient:
Data Integrity Impact
Assess the impact on data integrity:
Affected Batches/Studies
Please list affected batches or studies:
Investigation
Outline the investigation conducted:
CAPA (Corrective and Preventive Actions)
Detail the CAPA plan:
Re-test/Requalification Decision
State the decision regarding re-testing or re-qualification:
QA Disposition
Provide the QA disposition:
Approval
Signature of responsible individual:
Date: