Deviation Impact Assessment Template
Equipment Details
Equipment: CO2 Incubator
Area: Production/Cell Culture
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification: [Insert classification, e.g., Minor, Major, Critical]
Product/Patient Impact
Impact Assessment: [Insert assessment of product/patient impact]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [Insert affected batches or studies]
Investigation
Investigation Summary: [Insert summary of the investigation conducted]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert summary of corrective and preventive actions taken]
Re-Test/Requalification Decision
Decision: [Insert decision regarding re-test or requalification]
Quality Assurance Disposition
QA Disposition: [Insert QA disposition]