Regulatory Open Forum

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  • 1.  eQMS

    Posted 11-Apr-2018 11:09
    Hello,

    Does anyone have an eQMS they would recommend? We are a medical device company dealing with class I and class II attachments- thank you!

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    Lauren Combs Viker
    Quality Assurance Manager
    Grover Beach, CA 93433
    USA
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  • 2.  RE: eQMS

    Posted 17-Apr-2018 10:43
    There are a few that come to mind.  Grand Avenue Software is a very budget friendly and easy to use QMS.  I have used this twice, and both times I have had excellent service from the company.  Another that we just implemented for a client was QT9.

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    Jackie Torfin
    Global Director RA/QA
    Maple Grove MN
    United States
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  • 3.  RE: eQMS

    Posted 18-Apr-2018 03:01
    We used QT9 for a few years and found it a good cloud-based solution for a small company.  Unfortunately, due to several "crashes" recently, we decided to look at other solutions.  We selected QCDB from CAMA Software, but were also impressed by Greenlight Guru, ideal for a start-up company.

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    Larry Lugo
    Carlsbad CA
    United States
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  • 4.  RE: eQMS

    Posted 19-Apr-2018 17:05
    I would highly recommend MasterControl. They have a Spark product which is ideal for smaller companies who don't have a lot of resources for implementation. MasterControl has gone through quite a transformation in recent years and they've got a really user-friendly user interface and great quick-start tools.

    In my opinion, the most powerful aspect of MasterControl is the inter-connectivity. We use the Documents Module, CAPA Module, Complaints Module, etc. These systems talk to each other, forming a closed-loop system. A big plus is that the FDA uses MasterControl, so they know it well and don't feel the need to go digging, at least not in my experience.

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    Lillian Erickson
    QA/RA Director
    Salt Lake City UT
    United States
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