Re: Validation Of BPCS -- BPCS-L

We are not covered by FDA, but we do have ISO. What this means for us, is that our FORMS and LAYOUTS are certified. The accuracy of the data on the forms (e.g. shop paperwork) is not covered by ISO, which I think is crazy, but how the forms are used, and the appearance of what is there, that is what is important, so every time I change our shop paperwork, we need a new ISO revision # ... my last such change was to add to the labor ticket identification of the customer that we are making this part for, because we now have laid out our final assembly to be grouped by customer.

I have been looking into Sarbanes Oxley, and periodically send some e-friends a bunch of urls that I think do a good job of explaining the IT implications of this legislation ... it is not just for accountants, but perhaps understanding much of it is just for lawyers. I think that this does apply to BPCS and all ERP. Contact me off-line if you also interested in this. My studies are not far enough along to post a definitive explanation.

Robert,
 Validation (if you are in the Pharma Business) is not enough these days
you have to comply to CFR21 PART 11 guidelines that the FDA  published
which basically referring to 3 main points: security,audit trail,elctronic
signatures. each one is dealt differently .
we have done validation of version 6.04 - it a must and it is a long
process ,it has to be done again in every site because ,although the
system is "commonly used"
people make changes to the software,and the setup might be dif.,
can contact me off line for more info if needbe

Best Regards
Danny Monselise


"Robert M. Gauthier" <Rgauthier@xxxxxxxxxxxxxxxx>
Sent by: bpcs-l-bounces@xxxxxxxxxxxx
11/13/2003 08:34 AM
Please respond to "SSA's BPCS ERP System"

        To:     "BPCS-L@xxxxxxxxxxxx" <BPCS-L@xxxxxxxxxxxx>
        cc:
        Subject:        Validation Of BPCS


We are running BPCS 6.01.01 Mixed Mode:
   Would like to know if anyone has done a detail validation of BPCS by
Users for FDA approval or
have you excepted the fact that BPCS is already suppose to be FDA
approved. If you have done your
own validation I would like to talk to you, please contact me off-line
or share with us all, as others may need
this info.  Thanks in advance.
--

Best Regards, Robert M. Gauthier MIS Director


       Marietta
Corporation

Office: ( 607-753-6746 Ext - 437 P.O. Box 5250

Fax:       (  607-756-0656                                         37
Huntington Street

E-Mail :       Rgauthier@xxxxxxxxxxxxxxxx
<mailto:Rgauthier@xxxxxxxxxxxxxxxx>            Cortland, NY      13045

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