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09110 - FDA regulations regarding software validation
BAL Application Log Documentation TXBHW - Original Tax Base Amount in Local CurrencyThis documentation is copyright by SAP AG.
FDA regulations regarding software validation
View on-line via "Release Strategy in detail" and then part 34 OnlineCorrection Support or download PDF file and read pages 58-59 about same OCS
... should be just the kinda "talk" the auditors wanna hear ... 😎
Sorry for the step-by-step answer but I'm doing this in between loadsa other
things, a minute at a time, Louis.
> -----Original Message-----
> From: Louis.ForeeZctacalign.com [mailto:Louis.ForeeZctacalign.com]
> Sent: Thursday, January 30, 2003 14:02
> To: DoNotReply@consolut.eu
> Subject: RE: FDA regulations regarding
> software validation
>
>
> Catherine,
>
> Quick Link "releasestrategy" in the SAP Service Marketplace
> gets you there:
>
> https://websmp106.sap-ag.de/~form/sapnet?_SHORTKEY=00200797470
> 000022161&
>
> Regards, Louis.
>
>
> > -----Original Message-----
> > From: Louis.ForeeZctacalign.com [mailto:Louis.ForeeZctacalign.com]
> > Sent: Thursday, January 30, 2003 12:18
> > To: DoNotReply@consolut.eu
> > Subject: RE: FDA regulations regarding
> > software validation
> >
> >
> > Think that's in the Release Strategy booklet too, Louis.
> >
> >
> > > -----Original Message-----
> > > From: Catherine Paalvast [mailto:cpaalZams-partners.com]
> > > Sent: Thursday, January 30, 2003 12:17
> > > To: DoNotReply@consolut.eu
> > > Subject: FDA regulations regarding software
> > validation
> > >
> > >
> > > I'm installing support packages in our production system this
> > > weekend, and the organization's Quality Assurance Manager
> > > says that he needs descriptions of 'What is a Support Package
> > > and Why We Need to Install Them' in case the FDA (Food and
> > > Drug Administration for my overseas friends) comes in to do a
> > > system audit. (I'm at a company that makes bio-medical
> > > supplies and they are closely audited to ensure quality of
> > > product, processes, and systems).
> > >
> > > I searched SAPNet and can't find any white papers from SAP
> > > describing the benefits of Support Packages and staying
> > > current, just the occasional paragraph describing support and
> > > explaining fixes and enhancements.
> > >
> > > Does anyone have a document they could share that describes
> > > (non-technically) why we apply support packages to an R/3 system?
> > >
> > > Thanks!
> > >
> > >
> > > Catherine Paalvast
> > > Basis / iSeries Consultant
> > > AMS Systems Integration
> > > cpaalZams-partners.com
> > >
> > > [Non-text portions of this message have been removed]
> > >
> > >
> > > Have a look to our homepage at: http://www.consolut.net
> > > DoNotReply@consolut.eu
> > >
> > > Your use of consolut is subject to
> > > http://www.consolut.net
> > >
> > >
> >
> >
> > [Non-text portions of this message have been removed]
> >
> >
> > Have a look to our homepage at: http://www.consolut.net
> > DoNotReply@consolut.eu
> >
> > Your use of consolut is subject to
> > http://www.consolut.net
> >
> >
>
>
> [Non-text portions of this message have been removed]
>
>
> Have a look to our homepage at: http://www.consolut.net
> DoNotReply@consolut.eu
>
> Your use of consolut is subject to
> http://www.consolut.net
>
>
[Non-text portions of this message have been removed]
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