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  • 1.  Automated Tool for Risk Management -14971

    Posted 19-Jun-2018 12:13
    Edited by Aneeta Gujral 19-Jun-2018 12:16
    I am wondering which "tools" (software) are being used to automate the Risk management process ( pre + post production)in the Medical Device 
    Manual process is difficult to sustain.
    Appreciate your response!


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    Aneeta Gujral
    Carlsbad CA
    United States
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  • 2.  RE: Automated Tool for Risk Management -14971

    Posted 19-Jun-2018 15:50
    Hi, 
    I have heard about the Greenlight Guru's Medical Device Risk Management Software. I haven't personally tried it yet. Here is the link, if you're interested. Risk Management Software | Greenlight Guru

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    Sai Kunnath
    QA/RA Associate
    Ontario,Canada
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    Original Message


  • 3.  RE: Automated Tool for Risk Management -14971

    Posted 20-Jun-2018 08:41
    Hi Aneeta,

    We use Greenlight Guru software to manage our quality system, the tool is part 11 compliant and very good. They have an amazing support team and the risk management tool is efficient and easy to use. They have several webinars about their software and how it helps you to comply with 14971.

    Hope this helps!


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    Donna Philput
    Sr. QA/RA Specialist
    Columbus, Ohio
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    Original Message


  • 4.  RE: Automated Tool for Risk Management -14971

    Posted 20-Jun-2018 20:44
    Hi Aneeta,

    MasterControl.com has been helping small businesses with our Spark system, all the way up to large companies and even the FDA with Risk management and "Compliance Accelerated" for 25 years.

    Check out our website and let me know if I can show you a Webex demo sometime. 

    Enjoy your day!

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    Deric Glissmeyer
    Regional Director
    Salt Lake City UT
    United States
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    Original Message


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