Deviation Impact Assessment
Equipment Details
Equipment: HEPA Integrity Test System (Photometer + Aerosol Generator)
Area: Engineering
Criticality: Critical
Product Impact: Direct
Deviation Details
Description of Deviation: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Classification
Classification of Deviation: [Enter classification]
Product/Patient Impact
Impact Assessment: [Enter assessment of product/patient impact]
Data Integrity Impact
Data Integrity Assessment: [Enter assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Enter summary of investigation]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Enter summary of CAPA]
Re-test/Requalification Decision
Decision: [Enter re-test/requalification decision]
Quality Assurance (QA) Disposition
QA Disposition: [Enter QA disposition]