Deviation Impact Assessment Template

Equipment: RABS / Isolator

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Provide a detailed description of the deviation.

Classification

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

Product/Patient Impact

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

Data Integrity Impact

Evaluate the impact on data integrity and compliance.

Affected Batches/Studies

List all affected batches or studies related to the deviation.

Investigation

Outline the investigation process, including timelines and responsible parties.

Corrective and Preventive Actions (CAPA)

Document the CAPA plan to address the deviation.

Re-test/Requalification Decision

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

Quality Assurance (QA) Disposition

Provide the QA disposition regarding the deviation.