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  • 1.  Electronic Document Management Systems

    Posted 04-May-2016 11:31

    Curious to know what EDMS (if any) are in use to manage electronic documents in your work environment. Sharepoint? Documentum? Other? Does your system interface with submission software? Thanks. 

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    Celia White

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  • 2.  RE: Electronic Document Management Systems

    Posted 05-May-2016 09:41

    We are in the process of implementing the CARA EDMS from Generis built on top of Documentum.  Published output can be stored in CARA and the inter-document links are maintained.  Our external publisher can get the files directly from CARA, publish, then place the published output right back in CARA.

    __________________________

     

    Mark A. De Rosch, PhD

    Senior Vice President,

    Regulatory Affairs and Quality Assurance

    Akebia Therapeutics, Inc.

    245 First Street, Suite 1100

    Cambridge, MA 02142

     

     




    Original Message


  • 3.  RE: Electronic Document Management Systems

    Posted 05-May-2016 10:12
    Mark,

    Quick Q: 

    Do you have an option to store all the files in your server and synchronize the files in your server with the CARA server? 

    Thank you.  

    David



    Original Message


  • 4.  RE: Electronic Document Management Systems

    Posted 06-May-2016 14:06

    Yes.  But, to me, this almost defeats the purpose of having an EDMS, which has version control, workflows, etc.

     

    Kind regards,

     

    Mark

    __________________________

     

    Mark A. De Rosch, PhD

    Senior Vice President,

    Regulatory Affairs and Quality Assurance

    Akebia Therapeutics, Inc.

    245 First Street, Suite 1100

    Cambridge, MA 02142

     

    Office: (617) 871-1214

    Cell: (603) 714-5079

    Main: (617) 871-2098

    Fax: (617) 871-2099

    Email: MDeRosch@Akebia.com

    Web: www.akebia.com

    image001.png@01CF345F.B6E98B10

     

     




    Original Message


  • 5.  RE: Electronic Document Management Systems

    Posted 06-May-2016 15:05
    Mark,

    "...this almost defeats the purpose of having an EDMS..."

    When the CARA server is down, what would you do?

    It is an extra layer for safety and security purposes. 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



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    Original Message