By Beth on Thursday, July 8, 2004 - 11:39 am:

Does anyone have some examples of User Requirements Specifications (URS) for an HPLC that they'd be willing to share?
Thanks,
Beth

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By Tim on Monday, July 12, 2004 - 04:10 am:

A few qustions first:

Are you wanting a URS for just the HPLC instrument itself, or for software that will control it, acquire/process/report data from it?

Are you working in an environment that needs to comply with the FDA ruling on electronic records/signatures (21 CFR 11)?

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By Tom Mizukami on Monday, July 12, 2004 - 11:38 am:

Hi Beth,

If you just want a template to plug your requirements into Google for the Jett consortium and they have a process chromatography template you could adapt. http://www.jettconsortium.com/Sample%20 ... _URS_0.doc

For an HPLC specific example you could ask on the 21CFRPart11 group on yahoo. You might also try your vendor or try www.labcompliance.com. Good Luck.

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By Tom Mizukami on Friday, July 16, 2004 - 11:52 am:

Hi Beth,

As a followup there are some functional requirements here: http://www.infoworld.com/article/04/06/ ... ity_1.html