Ambient Warehouse – 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 Ambient Warehouse must maintain temperature within specified limits. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature Mapping Report
URS-002 Ambient Warehouse must maintain relative humidity within specified limits. M DQ-002 IQ-002 OQ-002 PQ-002 Humidity Mapping Report
URS-003 Access to Ambient Warehouse must be controlled and monitored. L DQ-003 IQ-003 OQ-003 PQ-003 Access Control Logs
URS-004 Ambient Warehouse must have a validated alarm system for temperature and humidity deviations. H DQ-004 IQ-004 OQ-004 PQ-004 Alarm System Validation Report
URS-005 Regular maintenance must be performed on the Ambient Warehouse equipment. M DQ-005 IQ-005 OQ-005 PQ-005 Maintenance Logs
See also  TEM / SEM (as GMP-supporting analytics) – Traceability Matrix (URS ↔ Tests)