Deviation Impact Assessment

Equipment: Isolator / RABS System

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

[Enter detailed description of the deviation here]

Classification

[Enter classification of the deviation here]

Product/Patient Impact

[Describe the potential impact on the product and/or patient here]

Data Integrity Impact

[Describe any potential impact on data integrity here]

Affected Batches/Studies

[List affected batches or studies here]

Investigation

[Summarize investigation findings here]

CAPA (Corrective and Preventive Actions)

[Detail the CAPA plan here]

Re-test/Requalification Decision

[Document the decision regarding re-testing or re-qualification here]

QA Disposition

[Provide QA’s final disposition here]