Inline pH Control System – 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 The system shall accurately control pH levels during compounding. H DQ-001 IQ-001 OQ-001 PQ-001 Calibration Records Pass/Fail
URS-002 The system shall provide alarms for out-of-spec pH levels. H DQ-002 IQ-002 OQ-002 PQ-002 Alarm Test Records Pass/Fail
URS-003 The system shall maintain an audit trail for pH adjustments. M DQ-003 IQ-003 OQ-003 PQ-003 Audit Trail Records Pass/Fail
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