Air Shower – Deviation Impact Assessment

Deviation Impact Assessment

Equipment: Air Shower

Area: Facility

Criticality: Major

Product Impact: Indirect

Deviation Details

Provide a detailed description of the deviation observed with the Air Shower.

Classification

Classify the deviation according to internal guidelines (e.g., Major, Minor, Critical).

Product/Patient Impact

Describe the potential impact on product quality and patient safety.

Data Integrity Impact

Assess the impact on data integrity related to the deviation.

Affected Batches/Studies

List any affected batches or studies that may be impacted by the deviation.

Investigation

Outline the steps taken during the investigation of the deviation.

CAPA (Corrective and Preventive Action)

Detail the CAPA plan developed to address the deviation.

Re-test/Requalification Decision

Document the decision regarding re-testing or re-qualification of the Air Shower.

QA Disposition

Provide the Quality Assurance disposition regarding the deviation assessment.

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