Regulatory Open Forum

 View Only

  • 1.  QMS Software Suggestions

    Posted 16-Apr-2019 09:07
    Hi all, we recently had a demo from Greenlight Guru for a QMS software.  Anybody using Greenlight currently?  Any thoughts?  Any other QMS software options that you are using and would recommend? 

    Would love to find something with an API or ability to upload items from another database.  Also, a procedure/document mgmt component that would allow procedures to be 'checked out'.

    ------------------------------
    Emilia Gonzalez
    Lyndhurst OH
    United States
    ------------------------------


  • 2.  RE: QMS Software Suggestions

    This message was posted by a user wishing to remain anonymous
    Posted 16-Apr-2019 12:35
    This message was posted by a user wishing to remain anonymous

    Have you tried ValGenesis?
    Original Message


  • 3.  RE: QMS Software Suggestions

    Posted 17-Apr-2019 12:43

    Hi Emilia,

     

    MasterControl can meet your QMS, API and upload needs, as well as procedures being checked out. Message me and I can tell you more. Enjoy your day! Deric

     




    Original Message


  • 4.  RE: QMS Software Suggestions

    Posted 18-Apr-2019 11:44
    No, I haven't - what are your favorite features of this software?

    ------------------------------
    Emilia Gonzalez
    Lyndhurst OH
    United States
    ------------------------------

    Original Message


  • 5.  RE: QMS Software Suggestions

    Posted 16-Apr-2019 16:12
    Hi Emilia,

    Our company has been using Pilgrim QMS software for past couple of years and we've been pretty satisfied with it.  As with other QMS systems is modular and you can tailor it to your needs i.e. SOP management, change controls, complaint handling etc. It's also compatible with ERP systems if your company is looking to go that route. 


    ------------------------------
    Mateusz Leszczak
    Regulatory Affairs Specialist / Regulatory Clinical Specialist
    Clifton NJ
    United States
    ------------------------------

    Original Message


  • 6.  RE: QMS Software Suggestions

    Posted 17-Apr-2019 08:38
    Emily,

    I have had one clients using IMSXpress which is a good starter for very small companies, Part 11 features, and does have a bulk upload, but not sure of the API.


     I had looked at others which were too expensive, and use Veeva for work I do with a large company. That can be an expensive system if all features used. I also used Documentum previously and that also is not inexpensive.

    You could try Master Control, who I met with last month at a conference.  They said they revised and repriced their Spark product offering to be competitive to attract smaller companies. Sounds like that could be had for about 10-15k? 
    ( used to be more like 25-40k annually).  I am going to revisit that to see if it will fit affordably for mid-stage companies.

    Good luck!

    Ginger



    Original Message


  • 7.  RE: QMS Software Suggestions

    Posted 18-Apr-2019 11:45
    Thanks, Ginger! That is super helpful information.

    ------------------------------
    Emilia Gonzalez
    Lyndhurst OH
    United States
    ------------------------------

    Original Message


  • 8.  RE: QMS Software Suggestions

    Posted 17-Apr-2019 09:06
    Hi Emilia,

    GreenLight Guru seems to be in the highest regard among all those that I know that use it.

    I've heard good things about Qualio. It has the ability to upload items from another database and procedure/doc management process for procedures to be checked out. 

    QMSWrapper is great for companies that are small (50 employees or less). 

    And as Ginger mentioned, I've heard great things about the MasterControl's new option for smaller/mid-size companies. 

    Good luck in your search!

    Thank you,
    Sam

    ------------------------------
    Sam Rajkumar
    Canada
    ------------------------------

    Original Message


  • 9.  RE: QMS Software Suggestions

    Posted 17-Apr-2019 10:38
    Hi Emilia,

    I've talked to a startup founder that used Greenlight Guru and was very impressed. From what I've researched, the value of it seems to be in the design & development documentation for startups looking to do a submission. The cost was prohibitive for my group but I think it could be invaluable for startups that are trying to minimize the costs of consultants and regulatory people. For software companies, they also have a tie-in with JIRA that would theoretically make design traceability a lot easier than manually tracking. 

    I've used Grand Avenue Software (GAS) at 3 companies now. They are an inexpensive option with a lot of module options including document control. I'm not sure on the ability to upload items from another database but I'm doubtful that it currently has that capability. 

    If I were to choose a software, it would probably be Armature. During a search similar to yours, I found they had great support options and the software seemed intuitive. I didn't experience the actual implementation and use of the system, unfortunately. 

    Good luck with the search! There is sooo much out there. 

    Maddi

    ------------------------------
    Maddi Myers
    Regulatory and Quality Project Manager
    Edina MN
    United States
    ------------------------------

    Original Message


Related Content