Suppository Leak Test Machine – 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 Verify the machine can detect leaks in suppositories. H DQ-001 IQ-001 OQ-001 PQ-001 Leak Test Results Log [Result Placeholder]
URS-002 Ensure audit trail logs are maintained for leak sensitivity. M DQ-002 IQ-002 OQ-002 PQ-002 Audit Trail Log [Result Placeholder]
URS-003 Confirm that the machine operates within specified leak sensitivity parameters. H DQ-003 IQ-003 OQ-003 PQ-003 Operational Qualification Report [Result Placeholder]
See also  Ophthalmic Holding Tank (Sterile/Pressurized) – OQ Protocol