Deviation Impact Assessment Template

Equipment: Fluid Bed Dryer

Area: R&D/Production

Criticality: Major

Product Impact: Direct

CSV Required: Yes

Deviation Details

[Insert detailed description of the deviation]

Classification

[Insert classification of the deviation]

Product/Patient Impact

[Insert details on how the deviation impacts the product or patient]

Data Integrity Impact

[Insert details on the impact to data integrity]

Affected Batches/Studies

[List affected batches or studies]

Investigation

[Insert findings from the investigation]

CAPA (Corrective and Preventive Action)

[Insert details of the CAPA plan]

Re-test/Requalification Decision

[Insert the decision regarding re-testing or re-qualification]

QA Disposition

[Insert QA’s final disposition on the matter]