Nanoparticle Reactor (Batch) – 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 mixing speed is adjustable between 100-1000 RPM. H DQ-001 IQ-001 OQ-001 PQ-001 Mixing Speed Calibration Record
URS-002 Temperature control within 20-80 °C. H DQ-002 IQ-002 OQ-002 PQ-002 Temperature Calibration Record
URS-003 Control addition rate of reactants between 1-50 mL/min. M DQ-003 IQ-003 OQ-003 PQ-003 Addition Rate Test Record
URS-004 Maintain reaction time of 10-120 minutes. M DQ-004 IQ-004 OQ-004 PQ-004 Reaction Time Log
URS-005 All critical parameters must be recorded in real-time. L DQ-005 IQ-005 OQ-005 PQ-005 Real-time Monitoring Report
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