Shaking Incubator – Deviation Impact Assessment

Deviation Impact Assessment Template

Equipment: Shaking Incubator

Area: Production/Cell Culture

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Describe the deviation encountered during the qualification activities.

Classification

Classify the deviation (e.g., Major, Minor, Critical).

Product/Patient Impact

Assess the potential impact on product quality and patient safety.

Data Integrity Impact

Evaluate the impact on data integrity related to the deviation.

Affected Batches/Studies

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

Investigation

Summarize the investigation process undertaken to assess the deviation.

CAPA (Corrective and Preventive Actions)

Document the corrective and preventive actions proposed or implemented.

Re-test/Requalification Decision

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

QA Disposition

Provide the Quality Assurance disposition regarding the deviation.

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Also Check:

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