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  • 1.  CAPA Software Recommendations

    Posted 08-Feb-2013 10:16
    Hello
    I am researching CAPA systems. I am seeking recommendations for an an 'off the shelf' solution appropriate for a mid-size CRO (approximately 100 employees). We will be transitioning from Excel.
     
    Any recommendations or advice welcomed.

    Thank you!
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    Ellen McCarthy
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  • 2.  RE:CAPA Software Recommendations

    Posted 17-Feb-2013 03:24
    There are some customizable open source ticketing system I would suggest to look into like http://www.redmine.org/ and http://trac.edgewall.org/ .
    There is a need for IT expertise to install and maintain them, as well as someone has to spend time on to learn how they work, however when the company can take ownership on these question what you basically going to have a highly flexible CAPA system including workflow, notifications, forms, etc. .
    Cheers!


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    Szabolcs Agai
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    Original Message


  • 3.  RE:CAPA Software Recommendations

    Posted 18-Feb-2013 08:36
    If you are looking for a product that has been used in pharma, look at Master Control.  http://www.mastercontrol.com/. They have cloud based soloution that may be cost effective for a company of 100.  Even though the prior recommendation was open source, you may find the cost of validation for the open source high enough make the decision to go with commerical software. I am not assoicated with Master Control, but have worked with companies that selected it.

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    Catherine Hosage Norman, Ph.D., RAC
    President and Founder
    Module 3 Solutions, LLC
    www.module3solutions.com
    603-546-1826


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    Original Message


  • 4.  RE:CAPA Software Recommendations

    Posted 19-Feb-2013 09:13
    Please take a look, if you haven't already, at previous threads on this board that discussed recommendations for CAPA or QMS software in general.
    - Software for quality and regulatory compliance - http://connect.raps.org/raps/communities/viewdiscussions/viewthread?GroupId=97&MID=708
    - Quality Management Systems - http://connect.raps.org/raps/communities/viewdiscussions/viewthread?GroupId=97&MID=1179

    In addition, there are several discussions on Elsmar, some examples:
    http://elsmar.com/Forums/showthread.php?t=21455
    http://elsmar.com/Forums/showthread.php?t=25825

    and a few on LinkedIn
    http://www.linkedin.com/groupItem?view=&gid=2070960&type=member&item=28504072&trk=group_search_item_list-0-b-ttl&goback=.gna_2070960
    http://www.linkedin.com/groupItem?view=&gid=78665&type=member&item=33940500&trk=group_search_item_list-0-b-ttl&goback=.gna_78665

    if you're using SharePoint, NextDocs and Qumas have some solutions tailored to CROs worth looking at

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    Michael Zagorski RAC
    Director of Q&R
    Sway Medical LLC
    Pittsburgh PA
    United States
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    Original Message


  • 5.  RE:CAPA Software Recommendations

    Posted 19-Feb-2013 12:09
    Ellen

    Words of warning: any configurable system requires much more validation effort than a standard tool like Excel
    An open system can be equally or more difficult to validate than a commercial system
    With CAPA systems the issue is rarely the system used, it's the badly documented contents

    It is a rare treat to see a well-run and compliant CAPA system

    Regards
    Siegfried

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    Siegfried Schmitt
    Principal Consultant
    PAREXEL
    Braintree, Essex
    United Kingdom
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    Original Message