RE: Validation Of BPCS

[McK King <McK.King@xxxxxxxxxxxx>]

Robert,

This is a broad answer to your question, but my limited understanding of FDA
system validation leads me to believe that each company using BPCS (or any
other software for that matter) must validate that system as it applies to
that company's own processes. 

Hopefully, several people will be able to give you feedback on how they were
able to achieve this, but if you are looking for a blanket statement that
BPCS is certified for FDA I think you will find it does not exist.

Sorry I cannot give you more than that.

Good day,



McK King
Sr. Business Analyst
BWAY Corporation
Phone: 770-645-4817
McK.King@xxxxxxxxxxxx


-----Original Message-----
From: Robert M. Gauthier [mailto:Rgauthier@xxxxxxxxxxxxxxxx]
Sent: Thursday, November 13, 2003 8:35 AM
To: BPCS-L@xxxxxxxxxxxx
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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