Deviation Impact Assessment Template

Equipment: Aqueous Buffer Preparation Tank

Area: R&D/Production

Criticality: Major

Product Impact: Direct

CSV Required: Yes

Deviation Details

Provide a detailed description of the deviation observed in the Aqueous Buffer Preparation Tank.

Classification

Classify the deviation based on its severity and potential impact.

Product/Patient Impact

Assess and document the potential impact on the product and patient safety.

Data Integrity Impact

Evaluate the effect of the deviation on data integrity and compliance.

Affected Batches/Studies

List all affected batches or studies that may have been impacted by the deviation.

Investigation

Outline the steps taken during the investigation of the deviation.

CAPA (Corrective and Preventive Actions)

Detail the CAPA measures implemented to address the deviation.

Re-Test/Requalification Decision

Document the decision regarding re-testing or re-qualification of the equipment.

QA Disposition

Provide the Quality Assurance disposition based on the findings of the assessment.