Top Pan Balance – Deviation Impact Assessment

Deviation Impact Assessment

Equipment Details

Equipment: Top Pan Balance

Area: QC Lab

Criticality: Critical

Product Impact: Direct

CSV Required: No

Deviation Details

Deviation Description: [Enter deviation details here]

Classification

Classification: [Enter classification here]

Product/Patient Impact

Impact Assessment: [Describe product/patient impact here]

Data Integrity Impact

Data Integrity Assessment: [Describe data integrity impact here]

Affected Batches/Studies

Affected Batches/Studies: [List affected batches/studies here]

Investigation

Investigation Summary: [Provide investigation details here]

Corrective and Preventive Actions (CAPA)

CAPA Summary: [Describe CAPA here]

Re-Test/Requalification Decision

Decision: [Enter re-test/requalification decision here]

QA Disposition

Disposition: [Enter QA disposition here]

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