Ultracentrifuge – 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 Ultracentrifuge must achieve specified RPM for particle separation. H DQ-001 IQ-001 OQ-001 PQ-001 Calibration Certificate
URS-002 Ultracentrifuge must maintain temperature within specified limits. H DQ-002 IQ-002 OQ-002 PQ-002 Temperature Log
URS-003 Ultracentrifuge must operate without imbalance during runs. M DQ-003 IQ-003 OQ-003 PQ-003 Imbalance Test Report
URS-004 Ultracentrifuge must have controls for RPM and temperature. M DQ-004 IQ-004 OQ-004 PQ-004 Control System Validation
See also  Extrusion Machine – Equipment Validation SOP