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  • 1.  Doc mgmt software

    Posted 13-Mar-2018 13:06
    Hello,
    Can anyone recommend document management software that is compliant with 21 CFR part 11?

    Thanks,

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    Sarah Green
    Knoxville TN
    United States
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  • 2.  RE: Doc mgmt software

    Posted 14-Mar-2018 09:31
    Hello Sarah,

    Veeva Vault and First Doc are some of the popularly used doc mgmt softwares.

    Alternatively, you can also use a document repository (e.g. Box) which updates the document version every time the document is updated and users have controlled access. In this case, you can draft a document which shows how the system complies with all parts of 21 CFR 11. It is quite easy, but in the long run, may get tedious.


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    Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC
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    Original Message


  • 3.  RE: Doc mgmt software

    Posted 14-Mar-2018 10:16
    Hi Sarah,

    I've had some experience recently with Greenlight Guru (Demo: Quality Management Software - Greenlight Guru), a new software geared exclusively to Medical Device (built around 13485/14971). It has a really unique and intuitive Design & Development Matrix tool and a Risk Matrix tool that I've never seen the equal of. They also have Part 11 compliant Document Control and Training modules. Those four products come in their basic package (Go), which is a flat rate and includes installation, configuration, validation, and user training. They also have a deluxe package (Grow) which includes the first four mentioned, plus CAPA, Complaints, etc.

    If you're not interested in the Medical Device Design & Development/Risk Matrix tool, I highly recommend MasterControl (Quality Management Software, Document Control Software - MasterControl Inc). I have used MasterControl extensively across three companies and ten years. It is an amazingly powerful, integrated software. It is a bit complex initially, but that complexity is a direct reflection of it's powerful capacity. It is a semi-configurable software, and can be made to do almost anything. MasterControl has 40+ product offerings to go along with Document Control. They have pricing models for small and large companies.

    Both of these are Part 11 compliant, both have a great interface. I'm happy to have a screen-share with you if you want to see how my company uses MasterControl every day. I find this more helpful then having a sales pitch right up front :)

    As for Green Light, I've only been demoing it so far (for the matrix tool), so I can't show you any real-life usage, but I can definitely recommend scheduling a demo if the matrix tool interests you.

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


  • 4.  RE: Doc mgmt software

    Posted 15-Mar-2018 08:16
    I have been using IMSXpress (from ISO Xpress) for very small clients.  No hard sell, much less expensive than Veeva, First Doc, Greenlight Guru and Master Control.  It has Part 11 design.

    Some systems do not play well with Apple OS or mobile so check on this.


    Remember all programs must be validated as suitable for your systems through some testing, after you install it.  And you need procedures and training for use of the system, including roles and access levels.  Someone (or 2 people) should be appointed administrators of the system, your "controllers". This control at your site completes the Part 11 compliance requirements.

    Good luck!

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com
    (+1) 715-307-1850



    Original Message


  • 5.  RE: Doc mgmt software

    Posted 14-Mar-2018 10:21
    There are a bunch.  Some of the long established players include Documentum (now part of OpenText) and QUMAS.  Veeva Vault is a newer cloud based solution that end-users tend to like.  Others I've come across are Pilgrim and MasterControl.  Many of these vendors offer other quality modules besides doc control so I suggest developing an overall quality IT strategy first so systems will work well/integrate together.

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    Patrick Kager
    Concord MA
    United States
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    Original Message


  • 6.  RE: Doc mgmt software

    Posted 14-Mar-2018 11:50
    Hello there,

    Many eQMS applications out there that have different features and functionality.  What I recommend to clients is to download the demo or ability to use the application for a short period of time.  Because there are two elements that need to be considered, 1) usability and 2) cost.  Is it cost effective or affordable for your organisation because there are free ones out there, low cost ones, and quite expensive ones with subscriptions.  Usability of the programs means can it do what you want it to do and maybe how much it can be tailored to what you need.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 7.  RE: Doc mgmt software

    Posted 15-Mar-2018 12:09

    Hi Sarah,

    I am confident that our EQMS (QualiPro) will exceed your expectations. Here is a brief overview, but we would be happy to schedule a demo for you.  

    http://emmainternational.com/wp-content/uploads/2018/03/EMMA-QualiProFlyer.pdf

    QualiPro is the only product on the market that is designed to meet the needs of a wide variety of industries in an intelligent manner. It is extremely user friendly, efficient and equipped with an unprecedent dashboard that enables the user to customize to their needs. QualiPro contains a host of modules that are integrated in real time to meet the needs of the user.

    Regards,

    Kira



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    Kira Jabri
    Farmington Hills MI
    United States
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    Original Message


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