RE: Validation Of BPCS

Just to shed a little light on this subject. FDA does NOT have a list of
validated ERP Systems. FDA validates the Company's controls, processes and
procedures a company puts in place to maintain and control the system.

When a company moves within the FDA environment one of your earliest task is
establishing a set of controls, who is responsible to maintain those
controls and define the procedure when changes must be made to those
controls, software, hardware etc.

As for the Operating System or ERP, you can either rely on a series of test
the manufacturer of said software has conducted proving the software
performs in a given manner each and every time. However most use the
manufacturers testing as only a starting point and create a detail set of
testing measures better know as Test Cases to prove the system does perform,
both prior to installation, modification, upgrades etc as well as after
developers have made changes to the base product. This however does not
exclude the End User from being exempt from the testing of changes to system
parameters as well. 

The objective here is to prove only the changes stated through a set of
specs will perform as stated and not cause any cascade effect to other
activities within the environment. 

Hope this helps some in the understanding of FDA Validation.


Jim Buono
Sr. Programmer / Analyst
YCI - IT BPCS Manufacturing Department.
(925) 924-3126
jbuono@xxxxxxx




-----Original Message-----
From: McK King [mailto:McK.King@xxxxxxxxxxxx] 
Sent: Thursday, November 13, 2003 5:44 AM
To: 'SSA's BPCS ERP System'
Subject: RE: Validation Of BPCS


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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