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
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)?
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%20Documents/Final/Chromatography_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.
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/04/06/25/26OPreality_1.html