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]