In-vitro Release Testing System (Dialysis/Flow-through/USP apparatus as applicable) – 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 Temperature must be maintained within specified limits during testing. M DQ-001 IQ-001 OQ-001 PQ-001 Temperature log Pass
URS-002 Agitation speed must be adjustable and validated. M DQ-002 IQ-002 OQ-002 PQ-002 Agitation calibration report Pass
URS-003 Flow rate must be consistent and within specified range. H DQ-003 IQ-003 OQ-003 PQ-003 Flow rate validation report Pass
URS-004 Sampling must be conducted at defined intervals. M DQ-004 IQ-004 OQ-004 PQ-004 Sampling log Pass
URS-005 Data capture must be accurate and reproducible. H DQ-005 IQ-005 OQ-005 PQ-005 Data integrity report Pass
See also  Ultrasonicator (Probe/Bath) – Deviation Impact Assessment

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