Deviation Impact Assessment
Equipment Details
Equipment: Sterilization System (EO/Gamma/E-beam)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Classification
Classification of Deviation: [Insert classification]
Product/Patient Impact
Impact on Product: [Insert detailed assessment of product impact]
Impact on Patient: [Insert detailed assessment of patient impact]
Data Integrity Impact
Impact on Data Integrity: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [Insert list of affected batches or studies]
Investigation
Investigation Summary: [Insert summary of investigation conducted]
Findings: [Insert findings of the investigation]
CAPA
Corrective Actions: [Insert list of corrective actions taken]
Preventive Actions: [Insert list of preventive actions taken]
Re-test/Requalification Decision
Re-test Decision: [Insert decision regarding re-testing]
Requalification Decision: [Insert decision regarding requalification]
QA Disposition
QA Disposition: [Insert QA disposition]