Cryo/Cold Storage (2–8°C / -20°C / -80°C) – 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 Equipment must maintain a temperature range of 2–8°C for NDDS intermediates. M DQ-001 IQ-001 OQ-001 PQ-001 Temperature mapping report
URS-002 Equipment must maintain a temperature of -20°C for DS storage. M DQ-002 IQ-002 OQ-002 PQ-002 Temperature mapping report
URS-003 Equipment must maintain a temperature of -80°C for DP storage. H DQ-003 IQ-003 OQ-003 PQ-003 Temperature mapping report
URS-004 Temperature mapping alarms must be functional and logged. H DQ-004 IQ-004 OQ-004 PQ-004 Alarm test report
URS-005 Audit trail must be maintained for all temperature excursions. M DQ-005 IQ-005 OQ-005 PQ-005 Audit trail log
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