SIP System (Tanks/Lines) – 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 SIP system must maintain a temperature of 121°C during sterilization. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature Log
URS-002 The SIP system must maintain a pressure of 2 bar during sterilization. H DQ-002 IQ-002 OQ-002 PQ-002 Pressure Log
URS-003 The SIP system must hold the sterilization parameters for a minimum of 30 minutes. M DQ-003 IQ-003 OQ-003 PQ-003 Hold Time Log
URS-004 The SIP system must provide real-time logging of temperature and pressure. M DQ-004 IQ-004 OQ-004 PQ-004 Real-time Log Records
URS-005 The SIP system must have alarms for deviations in temperature and pressure. L DQ-005 IQ-005 OQ-005 PQ-005 Alarm Test Records
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