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complaint handling and reporting software packages

  • 1.  complaint handling and reporting software packages

    Posted 11-Mar-2021 17:16
    I am hoping to get some recommendations from people here who've used Medical Device Quality Management System software packages that has complaint handling and medical device reporting modules. I'm also open to software packages that is purely for complaint handling and reporting though that is probably unlikely to exist as a stand-alone.

    It would be great if the software package can also handle customer service communications before the complaint process begins or if it can work well with other customer service software out there. Would also be nice if it's a cloud solution that can work globally + be able to do trending reports, etc.

    Thanks you!

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    Clarisa Tate
    Medical Devices, Regulatory/Quality/Engineering
    Bay Area, CA
    USA
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  • 2.  RE: complaint handling and reporting software packages

    Posted 12-Mar-2021 08:27
    Hi Clarissa

    I haven't tried it but Qualityze (EQMS) is built on the Sales Force (CRM) patform and their reps claim complaints can pull right in.

    Look them up, ask to see a demo..


    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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  • 3.  RE: complaint handling and reporting software packages

    This message was posted by a user wishing to remain anonymous
    Posted 12-Mar-2021 08:57
    This message was posted by a user wishing to remain anonymous

    I know Green Light Guru does free demonstrations, so perhaps request one and ask them.


  • 4.  RE: complaint handling and reporting software packages

    Posted 13-Mar-2021 11:46
    It has been a few years, but we trialed Master Control as a web-based solution (IIRC) - I don't recall the specific interfaces with CRM software but I seem to recall it had the ability to interface with other systems.

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    Scott Bishop
    Houston TX
    United States
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  • 5.  RE: complaint handling and reporting software packages

    Posted 15-Mar-2021 10:19
    Thank you to everyone that replied. I'll look into these software. If anyone wants to add more, please feel free.

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    Clarisa Tate
    Medical Devices, Regulatory/Quality/Engineering
    Bay Area, CA
    USA
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  • 6.  RE: complaint handling and reporting software packages

    Posted 15-Mar-2021 12:32

    I haven't worked with MasterControl myself, but I do recall from seeing other companies use it that they have a complaints module in addition to many others. From what I've seen of it, the system has great traceability, and I was very impressed with the clean UI. I recommend getting a demo from them.

    Personally I've used Epicor for complaint management, which had some integration with the CRM marketing/sales used (I believe it was Salesforce but not sure). I found Epicor's UI to be cumbersome. I had to implement an updated complaints module in it and we needed to use a lot of workarounds to implement it in the way I wanted. I wouldn't recommend it.



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    Hiral Dutia
    Regulatory Affairs Manager
    Third Pole Therapeutics
    Waltham, MA
    USA
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  • 7.  RE: complaint handling and reporting software packages

    Posted 15-Mar-2021 16:33
    Thank you, Hiral!

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    Clarisa Tate
    Medical Devices, Regulatory/Quality/Engineering
    Bay Area, CA
    USA
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  • 8.  RE: complaint handling and reporting software packages

    Posted 16-Mar-2021 08:24
    Just remember everyone that most startups are not well funded enough to afford the big packages like Master Control,  Veeva, Green Light Guru, which tend to run at 25k and up a year minimum, though i have heard it is more like 50k now for the mid-range tier.

    Qualityze, Grand Avenue software, IMSXpress, Enzyme are smaller, less expensive but stable softwares now.  But for many of these, every feature is extra.  Notl all, but many.


    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------



  • 9.  RE: complaint handling and reporting software packages

    Posted 16-Mar-2021 10:28
    Ginger - great point.

    I have heard great things about Grand Avenue from your list and from my experience worth a review as well.

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    Scott Bishop
    Houston TX
    United States
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  • 10.  RE: complaint handling and reporting software packages

    Posted 21-Mar-2021 23:25
    Hi Clarisa,

    I've worked with GreenlightGuru eQMS software - in the two years of experience, I've encountered numerous useful upgrades. They take customer feedback into account and improve their product. 
    They'll also send release notes for all upgrades, which is really useful. They respond to all queries ultra efficiently (via emails or calls). Customer service is really good. 
    They also publish all OQ/PQs, which come in handy for your audits/auditors.
    And as someone mentioned, they have free demo option.
    Hope it helps,
    Ana

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    AnaCiric
    RA/QA Specialist
    Singapore
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