Deviation Impact Assessment Template
Equipment Details
Equipment: Encapsulation Efficiency Measurement Setup (HPLC/UPLC + separation)
Area: QC/R&D
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description: [Enter description of the deviation]
Date of Occurrence: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification]
Product/Patient Impact
Impact Assessment: [Enter assessment]
Data Integrity Impact
Data Integrity Assessment: [Enter assessment]
Affected Batches/Studies
Batches/Studies Affected: [Enter affected batches/studies]
Investigation
Investigation Summary: [Enter investigation summary]
Corrective and Preventive Action (CAPA)
CAPA Summary: [Enter CAPA summary]
Re-Test/Requalification Decision
Decision: [Enter decision]
QA Disposition
Disposition: [Enter QA disposition]