Deviation Impact Assessment Template

Equipment: Tangential Flow Filtration (TFF) System

Area: R&D/Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description: [Insert detailed description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Type: [Insert classification type, e.g., Major, Minor]

Product/Patient Impact

Impact Assessment: [Insert assessment of product/patient impact]

Data Integrity Impact

Assessment: [Insert assessment of data integrity impact]

Affected Batches/Studies

Batches/Studies Affected: [Insert affected batches/studies]

Investigation

Investigation Details: [Insert details of the investigation conducted]

Corrective and Preventive Actions (CAPA)

CAPA Plan: [Insert details of the CAPA plan]

Re-Test/Requalification Decision

Decision: [Insert decision regarding re-test/requalification]

QA Disposition

Disposition: [Insert QA disposition]

Approval

Prepared By: [Insert name]

Reviewed By: [Insert name]

Approval Date: [Insert date]