Filter Housing (Sterile Grade) – 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 Filter housing must maintain pressure hold seal integrity during operation. H DQ-001 IQ-001 OQ-001 PQ-001 Pressure test report Pass
URS-002 Filter housing should be constructed of materials suitable for sterilization. M DQ-002 IQ-002 OQ-002 PQ-002 Material certification Pass
URS-003 Filter housing must be compatible with the sterilization method used. H DQ-003 IQ-003 OQ-003 PQ-003 Compatibility test report Pass
URS-004 Filter housing must be designed to prevent contamination. H DQ-004 IQ-004 OQ-004 PQ-004 Design review documentation Pass
URS-005 Filter housing must allow for easy access for maintenance and inspection. M DQ-005 IQ-005 OQ-005 PQ-005 Maintenance procedure documentation Pass
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