Regulatory Open Forum

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  • 1.  Regulatory Information System

    Posted 03-Sep-2015 12:15

    Do any of you have recommendations for an International Regulatory Management System  -that is affordable-  where we can manage all our product registrations, license numbers and expiration dates for over 125 countries? 

    We have looked at a few systems, but they are all too expensive and are mostly pharma based.  We need a simple, medical device registration management system.

    Thank you for your recommendations!

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    Diane Rogers
    Manager of Regulatory and International Affairs
    Ultradent Products Inc.
    South Jordan UT
    United States
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  • 2.  RE: Regulatory Information System

    Posted 12-Sep-2015 10:41

    I don't have a simple answer for you.  Your wedsite indicates that Ultradent Products sells a large number of products.  If all of these are listed internationally your task is significant.

    I don't know what you consider affordable however your current manual process probably costs more than you realize.  

    If this primarily requires tracking known regulatory compliance processes, it may be practical to use a generic project tracking program or to setup a database for this purpose.  

    Database development would incur an up-front cost but would not have significant maintenance costs other than entering data. This is best accomplished by a software developer that understand regulatory processes.  A rare combination of skills, however, I have worked with a consultant that is ideally suited for this.

    I hope this is helpful.

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    Russell Pizzuto
    President
    PPRE Consulting LLC
    Solon, Ohio 44139
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    Original Message


  • 3.  RE: Regulatory Information System

    Posted 17-Sep-2015 08:38

    Our business has recently begun the endeavor to tackle the same task, how to organize/manage our international registrations effectively. The business decided to invest capital, and had a software company customize their pharma-centric software for medical devices. It's an ongoing project and the benefit is yet to be seen.

    However, prior to that, we had a web database to keep track. Look into "Intuit QuickBase", you can customize the web app to create forms, different steps of registration, and automate reports. It's not an enterprise solution, but it's an affordable solution. We decided to switch because it was "too" customizeable and it became difficult to standardize reports across different business units. Hope this helps.

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    Ruth Pui
    Regulatory Affairs Specialist
    Dental Imaging Technologies Corp.
    Hatfield PA
    United States
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    Original Message


  • 4.  RE: Regulatory Information System

    Posted 17-Sep-2015 10:04
    Ruth,

    Thank you for sharing your experience.

    "We decided to switch because it was "too" customizeable and it became difficult to standardize reports across different business units."

    This commonly happens because firms look for software products without doing the following.

    - Develop your software specifications first - in other words, your "needs".  
    - Shop around to find a software product that meets your required specifications (needs).
    - Once it is found, validate the product to determine whether it conforms with your needs. 

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


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    Original Message


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