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  • 1.  GUDID Account Holder

    Posted 02-Mar-2017 09:39
    Hi Everyone, 

    I am trying to set up GUDID account for our company, and I wonder how many account coordinator we can have for one company and do they have separate login password? I notice there is no process that dictate the way for account change (like remove an user), does anyone has experience can share?

    Thanks in advance.

    ------------------------------
    Echo Yu
    Regulatory Associate
    echo.yu@sciex.com
    71 Four Valley Drive
    Concord, ON L4K 4V8 Canada
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  • 2.  RE: GUDID Account Holder

    Posted 03-Mar-2017 09:27
      |   view attached

    Hello Echo,

    This presentation I've attached from the FDA has a pretty good layout of the GUDID account hierarchy (see page 20). Each Coordinator account will have a separate login and password. However, the way you set it up is largely up to you. I work for a small company (50-200 employees) and I am the designated regulatory contact and the sole Coordinator. I have multiple Labeler accounts set up, which can be enabled or disabled as needed.

    I hope this helps!

    ------------------------------
    Brandon Bell
    Columbia SC
    United States
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    Attachment(s)

    pdf
    GUDID Overview Presentations.pdf   2.04 MB 1 version
    Original Message


  • 3.  RE: GUDID Account Holder

    Posted 03-Mar-2017 11:53
    Hi Echo-
    Each individual with GUDID access has their own user name and password.
    I would recommend having two coordinators so that you have a back up person.
    The primary role of the Coordinator (besides setting up the account) is to control the Label Data Entry (LDE) users who can create/view the data attribute entries for particular DUNS accounts in GUDID, as well as to add/remove additional label address DUNS for the master account.
    You can create as many LDE accounts as necessary.
    One person can act as the Regulatory Contact, the Coordinator and as an LDE.  
    The Regulatory Contact does not need to have either a Coordinator or LDE account unless they want one.
    best wishes,

    ------------------------------
    Stacey Henning
    GUDID Coordinator, RA Advisor
    Cardinal Health
    Waukegan IL
    United States
    ------------------------------

    Original Message


  • 4.  RE: GUDID Account Holder

    Posted 24-Jul-2017 12:05
    This is great information.  I actually have to go in and add the alternative code for our devices that have been granted an alternative to the UDI.  Must I do so for all SKUs of the device types?


    Thank you!

    ------------------------------
    Laura HoShue
    Regulatory Compliance Specialist
    Las Vegas, Nevada
    USA
    ------------------------------

    Original Message


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