Regulatory Open Forum

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  • 1.  QSR/ISO project tracking software

    Posted 13-Aug-2016 11:22


    Can anyone recommend a good software program for implementing/maintaining FDA QSR and ISO 13485 requirements?  I'm looking for one either with or without project tracking capabilities. 

    Thank you!

    Gretchen Upton RAC
    San Antonio TX
    United States

  • 2.  RE: QSR/ISO project tracking software

    Posted 15-Aug-2016 18:17

    I am wondering about the same thing.

    I could find a software to run the quality system but not to install one.

    I guess a detailed spreadsheet will be the most effective since there is not much that a software can do for the implementation!

    Leo Arya
    Valencia CA
    United States

  • 3.  RE: QSR/ISO project tracking software

    Posted 15-Aug-2016 18:31

    Does your firm employ SharePoint in any format? I have built our entire system (Quality, etc.) on SharePoint online. I've written our LIMs connected to it as well.

    There are many project-oriented tools available in SharePoint, including Gantt charting. The online version works so well with Office365. I've "part-11" provisioned it as well. Audit trails, user-roles, etc.

    We also employee SmartSheets when collaborative spreadsheets are required.

    Have a great day... I'm happy to help w/ any questions about either system if you have them!

    Jennifer Travis
    Front Range Labs
    Loveland CO
    United States

  • 4.  RE: QSR/ISO project tracking software

    Posted 15-Aug-2016 18:22

    I follow a podcast / blog like greenlight guru and they pitch their software, which I believe is for this purpose. They also have very good content on their blog / podcasts.

    Samir Shah
    Miami FL
    United States