Re: Validation Of BPCS

["Danny Monselise" <dannym@xxxxxxxxxxxxxxxx>]

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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