Deviation Impact Assessment for Qualification Activities
Equipment Details
Equipment: Tablet Checkweigher (Inline)
Area: Production/Compression
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter deviation description here]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Classification: [Enter classification]
Product/Patient Impact
Impact on Product: [Enter product impact]
Impact on Patient: [Enter patient impact]
Data Integrity Impact
Impact on Data Integrity: [Enter data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [Enter affected batches/studies]
Investigation
Investigation Summary: [Enter investigation summary]
CAPA (Corrective and Preventive Action)
CAPA Summary: [Enter CAPA summary]
Re-test/Requalification Decision
Decision: [Enter re-test/requalification decision]
QA Disposition
QA Disposition: [Enter QA disposition]