Regulatory Open Forum

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  • 1.  Electronic Document Management System

    Posted 30-Oct-2016 18:05
    I am currently working with a medical device company that needs global documentation connectivity based on FDA QSR and ISO Management Systems. We have supply chain management levels in Canada, Brazil, EU, US & China with the US as the holder of the EC and registered with FDA as Specification Developer , Manufacturer, and Distributor. All our contact suppliers in China are USFDA registered. I am looking for a document management system similar to Master Control and will offer training and software validation. Can someone recommend a system?


  • 2.  RE: Electronic Document Management System

    Posted 02-Nov-2016 16:49

    Did you check out veeva or qumas? 

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    Sahra Nguyen
    El Monte CA
    United States