Biosafety Cabinet (Class II/III) – Traceability Matrix (URS ↔ Tests)

URS ID URS Statement Risk (H/M/L) DQ Test Ref IQ Test Ref OQ Test Ref PQ Test Ref Evidence/Record Result
URS-001 Ensure proper airflow within the cabinet H DQ-001 IQ-001 OQ-001 PQ-001 Airflow Measurement Report [Result]
URS-002 Verify HEPA filter integrity H DQ-002 IQ-002 OQ-002 PQ-002 HEPA Filter Integrity Test Report [Result]
URS-003 Confirm containment capabilities M DQ-003 IQ-003 OQ-003 PQ-003 Containment Test Report [Result]
URS-004 Assess overall cabinet performance under aseptic conditions L DQ-004 IQ-004 OQ-004 PQ-004 Performance Validation Report [Result]
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Biosafety Cabinet (Class II/III) – DQ Protocol

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Biosafety Cabinet (Class II/III) – IQ Protocol

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Biosafety Cabinet (Class II/III) – OQ Protocol

Document Control: Document Number: OQ-BC-001 Version: 1.0 Effective Date: 2023-10-01 Reviewed By: [Name] Approval Date: [Date] Operational Qualification Protocol for Biosafety Cabinet (Class II/III) Objective: To validate the operational performance of the Biosafety Cabinet (Class II/III) to ensure it meets…