Zeta Potential Analyzer – Deviation Impact Assessment

Deviation Impact Assessment

Equipment: Zeta Potential Analyzer

Area: QC/R&D

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 product quality and patient safety]

Data Integrity Impact

[Assess the impact on data integrity]

Affected Batches/Studies

[List affected batches or studies]

Investigation

[Provide details of the investigation conducted]

CAPA (Corrective and Preventive Actions)

[Outline the CAPA plan developed]

Re-test/Requalification Decision

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

QA Disposition

[Provide QA’s final disposition on the deviation]

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