Regulatory Open Forum

 View Only

  • 1.  Software Package for ISO 14971 risk analysis

    Posted 27-Nov-2019 10:52
    Can anyone recommend a validated software package that helps administration and tracking of risk analysis activities based on ISO 14971.

    Regards
    Mike

    ------------------------------
    Mike Kilkelly
    Quality & Regulatory Affairs Manager
    Galway
    Ireland
    ------------------------------


  • 2.  RE: Software Package for ISO 14971 risk analysis

    Posted 27-Nov-2019 14:57
    The one that comes to my mind is Greenlight Guru's eQMS platform.

    ------------------------------
    Karen Zhou
    ------------------------------

    Original Message


  • 3.  RE: Software Package for ISO 14971 risk analysis

    Posted 28-Nov-2019 02:55

    Are you planning to use it just for Risk Analysis?

    Personally I have not come across a tool that offers just one part, this would not be a good business model! Most of the tools everyone knows, Q-Pulse, Greenlight Guru, Helix (Perforce) are all good but they offer the whole eQMS package. It might be something to look at but this all depends on your budget and future plans. 

    If you are just after RA then the cheapest tool I have worked with is Matrix Requirements. This is a requirement management tool but the RA and tracing works nicely, the price was also very reasonable when compared to others. 

    Hope this helps.



    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------

    Original Message


  • 4.  RE: Software Package for ISO 14971 risk analysis

    Posted 28-Nov-2019 08:28
    Greenlight Guru is presently in the process of updating to the new ISO 14971:2019, (hopefully it will be out by year-end if not it will be :2020).  The new software will have to be validated before it can be released, so it may be into 2020 before they can get it done.  Make sure that any package you purchase is being updated to the new edition of ISO 14971.  At this time, the EN ISO 14971 is not expected to be Harmonized to the new MDR/IVDR due to the lack of a working Harmonization process for the new regulations.  As soon as the EC issues a Harmonization Request, another EN version will be released.  Of course if that happens by year-end, it is possible that this could change.

    I would caution you that all software that can be configured to your quality system must be validated after it is installed in your facility.  Most software companies will provide validation packages to accomplish this activity.  Any time the software is updated it will need to be reviewed again to determine any validation requirements.

    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


Related Content