Deviation Impact Assessment
Equipment Details
Equipment: Spheronizer / Marumerizer
Area: Production/Pellets
Criticality: Major
Product Impact: Direct
CSV Required: No
Deviation Details
Description: [Enter deviation description here]
Date of Deviation: [Enter date]
Classification
Classification: Major
Product/Patient Impact
Impact Assessment: [Describe the product/patient impact]
Data Integrity Impact
Impact Assessment: [Describe the data integrity impact]
Affected Batches/Studies
Batches/Studies Affected: [List affected batches/studies]
Investigation
Investigation Summary: [Provide investigation summary]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Detail CAPA actions taken]
Re-test/Requalification Decision
Decision: [State re-test/requalification decision]
Quality Assurance Disposition
Disposition: [Provide QA disposition]