Regulatory Open Forum

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  • 1.  QMS software

    Posted 07-Mar-2017 17:36
    Edited by Leo Arya 07-Mar-2017 17:53
    hello everyone
    we are a class I device + some class II company.
    I would like to get a feedback from any of you where you have closely worked with a software to manage your QMS.( or Cloud based)
    there are tons of names out there but I need user feedback instead of cool marketing videos.


    your help is really appreciated.
    also I would like to have some capability to manage BOMs and DMRs even in a separate stand alone software.

    Thank you.

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    Leo Arya
    Valencia CA
    United States
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  • 2.  RE: QMS software

    Posted 08-Mar-2017 08:19
    Leo,
    I am a Solutions Consultant at greenlight.guru.  We are an eQMS specific for medical device companies with unique built-in capabilities for managing design controls and risk.  More information is available here: Quality Management Software | greenlight.guru
    Greenlight remove preview
    Quality Management Software | greenlight.guru
    Quality Management Software for Medical Device Manufactures | QMS Software
    View this on Greenlight >
    .  Let me know if you would like me to connect you with an Account Executive for more information.

    Best,
    Nichole

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    Nichole Leahy-Glass
    Noblesville IN
    United States
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  • 3.  RE: QMS software

    Posted 09-Mar-2017 07:29
    Hi Leo,

    I just had a client implement IMSExpress. Any system with features will require time to install, verify and administer it, but for a small company, this is a cool.system. Less than 5-10k for the initial year and lots of functionality. Much less expensive than other systems out there for very small companies.

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC
    715-307-1850





  • 4.  RE: QMS software

    Posted 13-Mar-2017 12:09
    thank you
    I have already talked to your team.
    appreciate your response.

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    Leo Arya
    Neotech
    Valencia CA
    United States
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  • 5.  RE: QMS software

    Posted 08-Mar-2017 09:49
    Hi Leo,

    We are currently implementing Verse Solutions, which is cloud based.  It is a child company of ETQ, an enterprise QMS software.  When we grow out of Verse, upgrading to ETQ should be seamless, according to them.  After doing several demos of different software we landed on Verse because of the number of modules you receive and the cost per year.  We are also a small company, making mostly Class II IVDs.   We haven't fully implemented so its hard to give a solid opinion of the software functionality, in practice.  I will say that their tech support is not great.  It takes them a long time to respond to our requests for assistance and usually we have to get our sales person involved to get any response.  It has been very frustrating. 

    Best of luck!
    Joy

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    Joy Pelfrey
    Director of RA/QA
    Norman OK
    United States
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