Deviation Impact Assessment
Equipment: Grade A/B/C/D Cleanrooms (Facility Qualification)
Area: Engineering
Criticality: Critical
Product Impact: Direct
Deviation Details
[Insert detailed description of the deviation here]
Classification
[Insert classification of the deviation here]
Product/Patient Impact
[Insert assessment of product/patient impact here]
Data Integrity Impact
[Insert assessment of data integrity impact here]
Affected Batches/Studies
[List affected batches/studies here]
Investigation
[Insert details of the investigation conducted here]
Corrective and Preventive Action (CAPA)
[Insert details of CAPA here]
Re-test/Requalification Decision
[Insert decision regarding re-testing/requalification here]
Quality Assurance (QA) Disposition
[Insert QA disposition here]