Deviation Impact Assessment Template

Equipment Details

Equipment: Analytical Balance (Micro/Semi/Analytical)

Area: QC Lab

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Classification of Deviation:

Product/Patient Impact

Impact on Product/Patient:

Data Integrity Impact

Impact on Data Integrity:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Details:

Corrective and Preventive Actions (CAPA)

CAPA Details:

Re-test/Requalification Decision

Re-test/Requalification Decision:

Quality Assurance (QA) Disposition

QA Disposition:

Approval

Approver Name:

Approval Date: