WFI Storage Tank – 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 WFI storage tank must maintain a temperature that ensures microbial integrity. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature Log Pass
URS-002 The WFI storage tank must be capable of being calibrated for temperature monitoring. M DQ-002 IQ-002 OQ-002 PQ-002 Calibration Certificate Pass
URS-003 The WFI storage tank must have a validated cleaning process to ensure microbial integrity. H DQ-003 IQ-003 OQ-003 PQ-003 Cleaning Validation Report Pass
URS-004 The WFI storage tank must be constructed of materials that do not leach contaminants. M DQ-004 IQ-004 OQ-004 PQ-004 Material Specifications Pass
URS-005 The WFI storage tank must have appropriate insulation to maintain temperature. L DQ-005 IQ-005 OQ-005 PQ-005 Insulation Audit Report Pass
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