Regulatory Open Forum

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  • 1.  Regulatory Commitment Tracking Tool?

    Posted 11-Jul-2013 08:22

    Hello,

    I'm interested in understanding the tools people have used to track regulatory commitments.  I've seen InfoPath, Excel, and Filemaker Pro utilized, but these can be cumbersome for various reasons. 

    Does anyone know of a useful software application available for managing and tracking global regulatory commitments?     

    Thanks, Rich

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    Richard Hoffman MS, RAC
    Indianapolis IN
    United States
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  • 2.  RE:Regulatory Commitment Tracking Tool?

    Posted 12-Jul-2013 06:40
    Rich,
    Can you please explain what you mean by global regulatory commitments and give some examples?
    Thanks
    Gadi

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    Gadi Shtepel
    Gadi Shtepel Ltd.
    Sgula
    Israel
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    Original Message


  • 3.  RE:Regulatory Commitment Tracking Tool?

    Posted 12-Jul-2013 07:32
    Hi Rich,

    Most organizations I've been with use "Trackwise" for their commitment tracking tool.  I believe it can be somewhat customized to meet specific needs and is fairly user-friendly.

    Hope this helps.

    Best regards,

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    Alan Traettino RAC
    Senior Director, Regulatory and Clinical Affairs
    Stryker Spine
    Allendale NJ
    United States
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    Original Message


  • 4.  RE:Regulatory Commitment Tracking Tool?

    Posted 12-Jul-2013 08:16
    We use our registration tracking software, which uses the Liquent InSight platform.  Commitments are entered as tasks in the system.  This was only implemented a little over a year ago, so we are still figuring out how to best set up and use the capabilities of the software to meet our needs. For example, we've found we need more choices than just "open" and "closed" for the status of the task.

    I'd be interested to know if there is any software designed more specifically for this purpose.  I would assume that one would have to use software designed for a broader purpose, in which case you're always going to have to figure out how to "work the system" to make it do what you want it to do.

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    Rachel Thornton
    Associate Director
    UCB
    Smyrna GA
    United States
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    Original Message


  • 5.  RE:Regulatory Commitment Tracking Tool?

    Posted 12-Jul-2013 10:17
    Hi Richard,

    Try BSI Entropy Enterprise Solution (www.bsiamerica.com). They might be able to help you. It was offered to me before, but our budget does not support it. So, I just use an Excel program and it is really painful - so don't go that route. If your company can afford it, I think it will be a good investment in the long run. They are cloud based system. My contact is Dan Griggs.

    Dan Griggs

    BSi business development manager

    c - 415-517-4555

    e - dan.griggs@bsigroup.com

    I hope this answers your question.

    Best regards,

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    Gilbert Pinzon
    E Systems Technology
    FREMONT CA
    United States
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    Original Message


  • 6.  RE:Regulatory Commitment Tracking Tool?

    Posted 15-Jul-2013 10:25
    Check out Global by Clinivation. I don't use it, but I do use their WorldView regulatory intelligence, which is a very helpful tool.

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    David S.
    Regulatory Manager
    Tenex Health
    Lake Forest CA
    United States
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    Original Message


  • 7.  RE:Regulatory Commitment Tracking Tool?

    Posted 16-Jul-2013 10:20
    Not sure what you meant by tracking regulatory commitments. But for regulatory compliance Trackwise is very efficient.  And if you were referring to regulatory submissions  MedXView or Octagon.  The latter software can also be used to  do the same function like Trackwise but it needs some developemnt work.

    Hope these helps.

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    Marie Joy Coraza
    Quality and Regulatory Affairs Director
    Spring TX
    United States
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    Original Message