Deviation Impact Assessment

Equipment: Viscometer / Rheometer

Area: QC/R&D

Criticality: Major

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation ID: [Enter Deviation ID]

Date of Deviation: [Enter Date]

Description: [Enter Description of Deviation]

Classification

Type: [Enter Type of Deviation]

Severity: Major

Product/Patient Impact

Impact Assessment: [Describe the impact on product/patient]

Data Integrity Impact

Assessment of Data Integrity: [Describe any data integrity concerns]

Affected Batches/Studies

Batch/Study IDs: [List affected Batches/Studies]

Investigation

Investigation Summary: [Summarize investigation process and findings]

CAPA (Corrective and Preventive Actions)

Actions Taken: [List actions taken to address the deviation]

Responsible Person: [Enter Name]

Due Date: [Enter Due Date]

Re-Test/Requalification Decision

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

QA Disposition

Disposition: [Enter QA disposition]

Reviewer: [Enter Name]

Date: [Enter Date]