Deviation Impact Assessment Template
Equipment Information
Equipment: CCIT System (Vacuum Decay/Helium/HVLD)
Area: QC/Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name and title]
Classification
Deviation Classification: [Enter classification]
Product/Patient Impact
Potential Impact on Product: [Describe potential impact]
Potential Impact on Patient: [Describe potential impact]
Data Integrity Impact
Impact on Data Integrity: [Describe potential data integrity issues]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide summary of investigation]
Root Cause Analysis: [Enter root cause analysis]
Corrective and Preventive Action (CAPA)
CAPA Plan: [Describe CAPA plan]
Responsible Person: [Enter name and title]
Due Date: [Enter due date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details: [Provide details if applicable]
QA Disposition
QA Disposition: [Enter QA disposition]
Reviewed By: [Enter name and title]
Date of Review: [Enter date]