Deviation Impact Assessment
Equipment Details
Equipment: Capsule Checkweigher
Area: Production/Capsules
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Classification: [Enter classification (e.g., Minor, Major, Critical)]
Product/Patient Impact
Impact Assessment: [Describe potential impact on product and patient]
Data Integrity Impact
Data Integrity Assessment: [Describe impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Summarize investigation findings]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Detail corrective and preventive actions to be taken]
Re-test/Requalification Decision
Decision: [State re-test or requalification decision]
Quality Assurance (QA) Disposition
Disposition: [Enter QA disposition]