Implant Sterilization System (EO/Gamma/Autoclave) – 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 ID 1]	Ensure sterilization cycle temperature meets specified requirements.	[H/M/L]	[DQ Test Ref 1]	[IQ Test Ref 1]	[OQ Test Ref 1]	[PQ Test Ref 1]	[Evidence/Record 1]	[Result 1]
[URS ID 2]	Verify that pressure during the sterilization cycle is maintained.	[H/M/L]	[DQ Test Ref 2]	[IQ Test Ref 2]	[OQ Test Ref 2]	[PQ Test Ref 2]	[Evidence/Record 2]	[Result 2]
[URS ID 3]	Confirm that the dose of sterilizing agent is adequate.	[H/M/L]	[DQ Test Ref 3]	[IQ Test Ref 3]	[OQ Test Ref 3]	[PQ Test Ref 3]	[Evidence/Record 3]	[Result 3]
[URS ID 4]	Ensure that an audit trail is generated and maintained.	[H/M/L]	[DQ Test Ref 4]	[IQ Test Ref 4]	[OQ Test Ref 4]	[PQ Test Ref 4]	[Evidence/Record 4]	[Result 4]

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