Deviation Impact Assessment Template

Equipment Details

Equipment: mAbs

Area: Media Preparation Vessel (Jacketed SS)

Criticality: Prepare sterile growth media

Product Impact: Production

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Deviation Classification:

Minor
Major
Critical

Product/Patient Impact

Describe Product/Patient Impact:

Data Integrity Impact

Describe Data Integrity Impact:

Affected Batches/Studies

List Affected Batches/Studies:

Investigation

Investigation Details:

CAPA

Corrective and Preventive Actions (CAPA):

Re-test/Requalification Decision

Re-test/Requalification Decision:

QA Disposition

QA Disposition:

Submit Assessment