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Connecting Complaints and Risk Analysis

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by QVarus, Aug 11, 2015.

  1. QVarus

    QVarus New Member

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    Looking to automate complaints and non-conformance reports input into risk analysis and CAPA. Can anyone recommend software that lets you set up electronic forms for each of these and then allows you to link them together?
     
  2. Nikki

    Nikki Well-Known Member

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    Following this post as I am curious about that myself.
     
  3. RoxaneB

    RoxaneB Moderator Staff Member

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    There are several packages out in the market that focus on feedback (positive or negative) and nonconformances. They do typically includes sections for corrections and corrective actions. They probably include options for preventive action. Not too sure, however, about the risk analysis as that is probably unique to each organization (i.e., scaling, weights, items to consider, etc.), but many options should include the ability to attach a file (such as your own risk analysis done in something such as Excel).

    Quality Management System software companies frequently offer modules for the various aspects of an ISO standard, including nonconformances and feedback. Or there are risk management software packages. If you're looking for something automated, the price tag will more than likely be high. And you'll need to consider # of licenses, location (your servers, external servers, cloud-based), training, customization, cost to upgrade (especially if you want your customizations transferred), maintenance, annual fees.

    If your organization already has a software package for document control, I'd recommend you contact the provider to see if they offer additional modules/packages for feedback and nonconformances. It may help on the automation - especially in linking actions to document revisions and training.

    If your organization does not have a software package for document control, you may get a multitude of recommendations from the members here...or you can narrow down the field based on your criteria and perhaps we can provide more focused thoughts on the top contenders (or things to ask them).
     
    Ronen E likes this.
  4. OrangeIsEnergy

    OrangeIsEnergy Member

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    We use QT9 Quality Management software for ISO 13485. It has modules for all aspects of ISO 13485 compliance (all sold as one package, not individually). We have not fully implemented the complaints, CAPA 7 RA sections yet, but are in the process of doing that. It doesn't necessarily automate the input of a complaint into an RA or CA or PA, but you do have the option to create a RA, CA or PA from complaint input and have them linked. we currently only use the software completely for doc control and training records, so I am not totally fluent in the other modules, but think it may have what you are looking for. Let me know if you have any questions about it. (for the record I have no affiliation with the manufacturer of the software, I just did a lot of research on companies that offer doc control software and such and really like QT9 so far).
     
    Ronen E likes this.

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