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  • 1.  RA tracking and submission software

    Posted 09-May-2017 14:18
    Hello,

    Just wondering what software people would recommend for tracking global registrations, sharing documents and submission workflows?

    Thanks,
    Tammy

    Tamara Davis | RA/QA Manager III | Bio-Rad Laboratories, Inc. | 5500 E Second Street, Benicia, CA 94510 | TEL 510-741-4631 | MOBILE 510-229-8532 |tamara_davis@bio-rad.com


  • 2.  RE: RA tracking and submission software

    Posted 10-May-2017 11:44
    I'd love to help, but I've never had the luxury of working in an organization large enough and with enough money to invest in this type of software. Our limited RA budgets for software went to e-submission software and at times Reg Intelligence tools.

    We always managed (and still do) all aspects of submission tracking with Excell workbooks of various complexity.

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States
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    Original Message


  • 3.  RE: RA tracking and submission software

    Posted 11-May-2017 03:04
    There are software packages out there but one solution may not be able to do everything that you require.  Setting up Regulatory Information Management (RIM) systems in a large organisation can be a multi-year effort which many businesses are currently engaged in.  Have you seen the Gens white paper on RIM systems?
    Pursuing World Class Regulatory Information Management (RIM); Strategy, Measures and Priorities Annual RIM Whitepaper 2016 Summer Edition
    This may give you some insight as to where the industry is on this topic
    Regards
    Ruth

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    Ruth Hunter
    Lifescan Scotland Ltd
    Inverness
    United Kingdom
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    Original Message


  • 4.  RE: RA tracking and submission software

    Posted 11-May-2017 03:24
    Edited by Simona Ioana Ulea 11-May-2017 03:25
    Hi Tamara,

    You can take a look also at <g class="gr_ gr_29 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="29" data-gr-id="29">Ennov</g> software. While it is able to store, share, review regulatory documents, it has also the ability to get adapted to the FDA eCopy specifications.

    Ennov, Inc. - <g class="gr_ gr_27 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="27" data-gr-id="27">Ennov</g>, Software for Life


    Kind Regards,

    Ioana <g class="gr_ gr_28 gr-alert gr_spell gr_inline_cards gr_disable_anim_appear ContextualSpelling ins-del multiReplace" id="28" data-gr-id="28">Ulea</g>
    Regulatory Affairs Professional
    Brussels, Belgium
    ------------------------------

    Original Message


  • 5.  RE: RA tracking and submission software

    Posted 11-May-2017 14:07
    Any idea if these software products, such as Ennov, have been successfully used for medical devices? They all seem to apply to drug or biologic products.

    Thanks for any information about use with devices.


    Original Message


  • 6.  RE: RA tracking and submission software

    Posted 12-May-2017 04:22
    Hi John,

    Yes, <g class="gr_ gr_20 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="20" data-gr-id="20">Ennov</g> is suitable to be used for medical devices. It has also a user-friendly dashboard to track deliverables depending on their deadline.

    ------------------------------
    KR,

    Ioana Ulea
    Regulatory Affairs Professional
    Brussels, Belgium
    ------------------------------

    Original Message


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