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Re: URS

olopez6102@... — Sun, 12 Oct 2008 17:37:13 GMT

Intended use? Cheersn Orlando Lopez Sent via BlackBerry by AT&T ... From: "Greg Ventura" Date: Fri, 10 Oct 2008 18:09:21 To:

Re: URS

Greg Ventura — Fri, 10 Oct 2008 22:13:54 GMT

I would agree. It also is not really helpful. There could be plenty of features that you don't really care about. Why even bother with them? There will

Re: URS

Mark Narain — Fri, 10 Oct 2008 22:01:14 GMT

Hi, I have seen people write URS based on the vendor supplied system literature. Especially for off the shelf system. Huge amount of resources are spent on

Re: interference testing for wireless system

Orlando Lopez — Thu, 09 Oct 2008 13:14:21 GMT

RJ, Maybe related with CPG 425.400 and/or 211.68. Cheers, Orlando Lopez olopez@... ... From: hlsinnovations

Re: URS

Orlando Lopez — Thu, 09 Oct 2008 13:14:21 GMT

Saludos a todos, Follow GAMP, ASTM E 2500, or any other software development methodology.... Cheers, Orlando Lopez olopez@... ... From:

Re: Software validation tests

mario_giampietro — Thu, 09 Oct 2008 13:14:11 GMT

Hi, Gamp4/Gamp5 stablish the test scope by software category, use this chapter of Gamp to know what kind of tests you have to perform. Mario Brazil - Computer

Re: interference testing for wireless system

hlsinnovations — Thu, 09 Oct 2008 10:26:41 GMT

Not quite sure what this has to do with electronic record keeping - but at the every least you need to provide way more information. - Type of system (PCs,

Re: URS

hlsinnovations — Thu, 09 Oct 2008 10:26:20 GMT

This to me is whether you require a URS and GAMP or just an RFQ and perhaps an FD. If you are speaking about software for the pharmaceutical industry that will

Re: Software validation tests

Orlando Lopez — Thu, 09 Oct 2008 10:26:03 GMT

To make my replay short...Assuming that you will be using a software package, the testing in the?qualify the application is based on the intended use,

Re: interference testing for wireless system

Orlando Lopez — Thu, 09 Oct 2008 10:25:57 GMT

Saludos Ali, Try http://www.ibm.com/Search/?sn=1&q=wireless+and+testing&v=16&lang=en&cc=us&en=utf&Search=Search or Chapter 17 in ?Computer Infrastructure

interference testing for wireless system

Ali Nejat — Thu, 09 Oct 2008 00:25:14 GMT

Hi; Does anyone can guide me how can I perform interference testing for wireless system? thanks [Non-text portions of this message have been removed]

Software validation tests

ehab_talal — Thu, 09 Oct 2008 00:24:59 GMT

Dear Sir, My question is about the contents of the Software validation protocols in general, We have a software validation master plan that refers to the

R: [21cfrpart11] URS

Minà, Francesco [GPSIT] — Tue, 07 Oct 2008 19:48:18 GMT

Dear Carlos The requirement document plays a key role for good engineering&software practices and principles. IEEE have defined standards for requirements

Re: URS

Martin G. Knop — Tue, 07 Oct 2008 19:48:07 GMT

I agree 100%. The user requirements are also used as a source in documenting the GxP impact assessment. ... [Non-text portions of this message have been

Re: Password aging

Thomas Quinn — Tue, 07 Oct 2008 15:18:20 GMT

jjacksonagile, The rule says: § 11.300 Controls for identification codes/ passwords. Persons who use electronic signatures based upon use of identification