Deviation Impact Assessment Template

Equipment Details

Equipment: Vacuum Transfer System (Mobile)

Area: Production/Material Transfer

Criticality: Major

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Insert detailed description of the deviation]

Date of Deviation: [Insert date]

Classification

Classification Level: Major

Product/Patient Impact

Impact Assessment: [Describe the potential impact on product quality and patient safety]

Data Integrity Impact

Assessment: [Describe any data integrity concerns associated with the deviation]

Affected Batches/Studies

List of Affected Batches/Studies:

• [Batch/Study 1]
• [Batch/Study 2]
• [Batch/Study 3]

Investigation

Investigation Summary: [Provide a summary of the investigation conducted]

Root Cause: [Identify the root cause of the deviation]

Corrective and Preventive Actions (CAPA)

CAPA Summary: [Outline the corrective and preventive actions taken]

Re-test/Requalification Decision

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

Quality Assurance Disposition

Disposition: [Provide QA’s final disposition on the deviation]