mAbs – 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	Ensure equipment operates within specified temperature range	H	DQ-001	IQ-001	OQ-001	PQ-001	Temperature logs	Pass
URS-002	Verify equipment can handle specified batch sizes	M	DQ-002	IQ-002	OQ-002	PQ-002	Batch size reports	Pass
URS-003	Confirm equipment meets required cleaning validation standards	H	DQ-003	IQ-003	OQ-003	PQ-003	Cleaning validation records	Pass
URS-004	Ensure equipment can maintain specified pH levels	H	DQ-004	IQ-004	OQ-004	PQ-004	pH measurement logs	Pass
URS-005	Verify equipment has adequate safety features	M	DQ-005	IQ-005	OQ-005	PQ-005	Safety feature documentation	Pass

Also Check: