Lyophilizer (Freeze Dryer) – 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]	The lyophilizer must maintain specified shelf temperature during the freeze-drying process.	[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]	The lyophilizer must achieve and maintain vacuum pressure as per specifications.	[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]	The lyophilizer must follow the defined cycle profile for optimal product stability.	[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]	The lyophilizer must provide an audit trail for all processes and parameters.	[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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