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  • 1.  QMS management platform

    Posted 07-Nov-2022 06:37
    Good morning,

    I'm dealing with the management of my company's Quality system, not only for the FDA but for ISO13548 as well. Can anyone recommend some online platforms that can help me manage both regulations? 

    Best regards

    ------------------------------
    Ana Clemente
    Portela
    Portugal
    ------------------------------


  • 2.  RE: QMS management platform

    Posted 07-Nov-2022 07:29
    Hello Ana.

    Try Qualio eQMS- a popular cloud based platform that is highly configurable and claims it meets ISO-13485 certifications upon audits.

    Review this page to  learn more on Qualio and ISO-13485.
    https://www.qualio.com/blog/iso-13485-medical-device-quality-management-system 

    This link below  on the other hand-apart from referencing best practices compliance changes by an entity to fulfill ISO-13485 also includes a request for the Qualio Toolkit.
    https://www.qualio.com/blog/iso-13485-2016-changes 

    I cannot attest as to how good the toolkit is, that's  for you evaluate-am not familiar with it yet-I also just requested my own copy.

    Cheers,
    Ram B

    ------------------------------
    Ram Balani
    CEO
    FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
    Amawalk , New York
    rbalani@fdasmart.com
    2019130558
    https://tinyurl.com/2wkxp69y
    on US FDA eSTAR for 510(K)
    ------------------------------

    Original Message


  • 3.  RE: QMS management platform

    Posted 08-Nov-2022 08:58
    Good day Ana,

    I would try Greenlight Guru or Intellect.  They both specialize in medical devices only.

    We found that Qualio was too expensive to incorporate their training module as every employee of the company had to have an email address.

    Best regards,

    ------------------------------
    D Michelle Williams
    VP - Operations
    United States
    ------------------------------

    Original Message


  • 4.  RE: QMS management platform

    Posted 09-Nov-2022 06:34
    See my earlier comments on this topic. Don't just blindly select a product based on someone's recommendation. First follow the GHTF Purchasing guidance. Second establish your requirements in writing for this product. Third follow the Purchasing guidance. This is a product affecting the quality of your product, treat it as such. FDA has released a new guidance in this area as well, but I have not had time to read it.

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

    Original Message


  • 5.  RE: QMS management platform

    Posted 09-Nov-2022 08:42
    I still recommend ISOExpress..  lower price point and great interface where you can see all docs in your document library or in draft, and create cabinet folders that show like a regular drive.  Great for overview of everything there.

    Interface reminded me a little of Docubridge or Documentum (for thie working in the Pharma space).

    In additioon to document management,  it has change control, quality audit, supplier, equipment management, non-conformance, places to hold/track equipment calibration records and complaint management modules, amongst others.

    Very nice price points.

    Designed to be compliant with part 11 with e- signatures.  







    Original Message


  • 6.  RE: QMS management platform

    Posted 10-Nov-2022 14:45
    Hello Ana,

    Check out ZenQMS. My company changed to ZenQMS and it has been excellent.

    ------------------------------
    Diane Kumar
    Cham
    Switzerland
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    Original Message


  • 7.  RE: QMS management platform

    Posted 11-Nov-2022 09:25
    Good Morning,
    We have been using QT9 for several years and find the price point and support to be excellent for a robust ISO 13485 compliant system.  They just launched QT9 University for additional training opportunities at no cost which is great as we continue to expand our team.
    We are currently finishing up Supplier Evaluations and Customer Surveys and find the modules to be very intuitive.  Document Control has everything you might want and the ISO Functions (like CAPAs) are logically designed.

    Best,

    ------------------------------
    Maureen Miller
    General Counsel & RA Director
    Lake St Louis MO
    United States
    ------------------------------

    Original Message


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