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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 _______________________________________________ This is the SSA's BPCS ERP System (BPCS-L) mailing list To post a message email: BPCS-L@xxxxxxxxxxxx To subscribe, unsubscribe, or change list options, visit: http://lists.midrange.com/mailman/listinfo/bpcs-l or email: BPCS-L-request@xxxxxxxxxxxx Before posting, please take a moment to review the archives at http://archive.midrange.com/bpcs-l. _______________________________________________ This is the SSA's BPCS ERP System (BPCS-L) mailing list To post a message email: BPCS-L@xxxxxxxxxxxx To subscribe, unsubscribe, or change list options, visit: http://lists.midrange.com/mailman/listinfo/bpcs-l or email: BPCS-L-request@xxxxxxxxxxxx Before posting, please take a moment to review the archives at http://archive.midrange.com/bpcs-l.
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