Regulatory Open Forum

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  • 1.  Regulatory Intelligence - tools, tips and tricks

    Posted 24-Oct-2013 07:19
    Hello All,

    I am just looking solution for more effective regulatory intelligence process mainly focused on standards.
    Manual checking takes a huge amount of time, is not efficient and human mistakes can easily occur.
    Main problem there is no additional resources to involve more personnel.
    Waiting for your advices.

    Additionally, problem after identification of new standards, guidelines or laws is implementation of them. Newsletters seem not to be efficient and creation of them requires a lot of knowledge, competence and again time. Maybe someone has a good solution on it.

    Thanks!

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    Aiste
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  • 2.  RE:Regulatory Intelligence - tools, tips and tricks

    Posted 25-Oct-2013 10:30
    Aiste:

    Take a look at Graematter's system (www.graematter.com).  I took part in the beta test, and it worked well for monitoring and searching various regulatory parameters of regulatory intelligence.  I believe the system is now offered commercially.  They seem to be expanding the scope of the system on a regular basis.

    Hope this helps.

    Peter

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    Peter A. Takes, Ph.D., RAC, FRAPS
    Vice President, Regulatory & Clinical Affairs and Quality Systems
    Kypha, Inc.
    Saint Louis, MO
    United States
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