Deviation Impact Assessment Template

Equipment Details

Equipment: Spray Dryer (Respirable Particles)

Area: R&D/Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Classification of Deviation:

Major
Minor
Critical

Product/Patient Impact

Describe the impact on product/patient:

Data Integrity Impact

Describe the impact on data integrity:

Affected Batches/Studies

List affected batches/studies:

Investigation

Investigation Details:

Corrective and Preventive Action (CAPA)

CAPA Details:

Re-test/Requalification Decision

Re-test/Requalification Decision:

Quality Assurance (QA) Disposition

QA Disposition: