Regulatory Open Forum

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  • 1.  Electronic NC - CAPA Documentation Systems

    Posted 26-Feb-2013 08:59
    I would be interested in any recommendations (pro or con) and experiences (good or bad) any one has had in selecting, implementing and/or maintaining Electronic Non-conformace and CAPA documention systems.  Thank you.
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    David Henninger RAC
    United States
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  • 2.  RE:Electronic NC - CAPA Documentation Systems

    Posted 27-Feb-2013 02:39
    David
    The best system I have ever seen was a manual one, though I was stunned because it was run by a large company with many NCs.
    The worst systems (totally ineffective and with meaningles contents) were TrackWise systems. That is not the fault of the software, which is superbly capable - it is the fault of the users who simply cannot cope with it.
    No software replaces the amount of input from the users, it only permits easier search for records and probably patterns, plus it provides a prescribed workflow.
    Those companies that chose software, e.g. TrackWise, found it worked best if used vanilla, i.e. without customisation.
    Don't underestimate the time from system evaluation to getting it running - one year is very fast, two years the norm. And then you need to get it into a stable state of operations
    Don't get me wrong, I really think a computerised system is a must have, but a month more planning can save you years of agony
    Siegfried

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


  • 3.  RE:Electronic NC - CAPA Documentation Systems

    Posted 28-Feb-2013 09:51
    In my experience, successful CAPA system doesn't depend on a sophisticated software. It requires a team who understand the scope of the problem and involve personnel who can fix the root of the problem (not superficial fixes). The solution has to work for the patient, user and business. A compliant CAPA form and simple MS Excel sheet can do the job. The key to successful CAPA system is, team has the "right"  attitude and support from the management.

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    Goldy Singh
    VP Quality & Regulatory
    Profound Medical Inc.
    Toronto ON
    Canada
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    Original Message