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Former Member

Regulatory Affairs Application

Dear All

Our company is looking for some monitoring and management tools for regiteration of Pharma Finished products with FDA local and other countries where we are exporting.

Features we are looking for includes:

Status of regiteration

Documents to be submitted

Objection by regulatory authorities

expiration and re-registration

We are currently having SAP ECC 6.0 and are Licensed to use SAP Business Suit.

please proose any application which can provide us above mentioned features.



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1 Answer

  • Posted on Jul 03, 2011 at 03:26 PM

    Hello Zeeshan

    I would suggest a bundle of solutions to be used which could be implemented step wise.

    1.) using SAP EHS MANAGEMENT you can:

    Handle the management of "Status of registration" (store data; extract data, analyse data); you can store and handle documents of any type; you can handle the data of "status of registration" and therefore expiraton dates can be handled; you can handle data describing the "objections" of authorities too.

    In the SAP EHS Standard property tree I do not know a property there you could handle the topic of "documents which have been submitted" and those which you haven't but it is easy to enlarge the data model of SAP EHS MANAGEmENT so in principle there is a solution available.

    2.) If you are more interested in the relation of "commucation"/"Collaboration" etc. with authorities etc. you could think about to use SAP Product and REACH Compliance Suite (in some sense) on the top of SAP EHS MANAGEMENT

    SAP EHS MANAGEMENT and SAP Product and REACH Complaice suite can be installed on one ECC 6.0 ERP system

    On the long term SAP will support better the e.g. "FDA" needs in SAP Product and RECH Compliance suite; but in principle I believe you can use this tool now to handle partly you business demand.

    3.) You could use SAP GTS to handle some of your demands too. SAP GTS would be installed on a seperate plattform (separate SAP license). You can integrate the logistic process running in ERP with SAP GTS so that if a "registration" expires logistic processes will be blocked.

    Please refer to SAP online help regarding the mentioned solutions and SAP pages to get a better idea what these tolls can be used for etc.

    With best regards


    Edited by: Christoph Bergemann on Jul 3, 2011 5:27 PM

    Edited by: Christoph Bergemann on Jul 3, 2011 5:28 PM

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    • Former Member

      Hi Christopher

      Thanks for sharing info, i will look into the features of SAP EH&S, and SAP Product and REACH.