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==== Validation for OI (OpenInsight 32-bit Specific) ====
=== At 17 JUN 2003 12:58:14PM [url=http://www.sprezzatura.com" onMouseOver=window.status= Click here to visit our web site?';return(true)]The Sprezzatura Group[/url] wrote: ===
{{tag>"OpenInsight 32-bit Specific"}}
We're with a client at the moment who works with lab samples and they are interested in whether OI has any form of "Validation" specifically with reference to FDA 21 CFR Part 2. Any and all comments appreciated as this means nothing to us .
[url=http://www.sprezzatura.com" onMouseOver=window.status= Click here to visit our web site?';return(true)]The Sprezzatura Group[/url]
[i]World Leaders in all things RevSoft[/i]
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=== At 17 JUN 2003 01:32PM Donald Bakke wrote: ===
Sprezz,
Well, it means absolute nothing to us as well but every online search we have done refers to Part 11 and is connected to digital signature validation. Here's one [url=http://www.validationassociates.com/Part11Center.html]website[/url] that seems to have a lot of information.
dbakke@srpcs.com
[url=http://www.srpcs.com]SRP Computer Solutions, Inc.[/url]
[img]http://www.srpcs.com/srpicon1.gif[/img]
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=== At 17 JUN 2003 01:51PM [url=http://www.sprezzatura.com" onMouseOver=window.status= Click here to visit our web site?';return(true)]The Sprezzatura Group[/url] wrote: ===
Wow that IS a good site - thanks! Our reading would be that the client has to get their software validated NOT the underlying OI system.
[url=http://www.sprezzatura.com" onMouseOver=window.status= Click here to visit our web site?';return(true)]The Sprezzatura Group[/url]
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[[https://www.revelation.com/revweb/oecgi4p.php/O4W_HANDOFF?DESTN=O4W_RUN_FORM&INQID=NONWORKS_READ&SUMMARY=1&KEY=4CFB1A5F64A6835F85256D48005D3916|View this thread on the forum...]]