Conclusion – it doesn’t have to hurt if you chose right!

1st rule of management effectiveness:

“You get what you inspect, not what you expect!”

Louis V. Gerstner, Jr.

Being dis-organized is usually the Achilles heel of a smooth-running audit, but being organized can make your life a lot easier. Make sure you know where to find records and documents that are used daily and offload all those that you don’t use. This will make it easier for you as well as for the auditor to get to the fundamental issues of your processes.

So, invest in a Quality Management Software – implement eQMS designed with compliance in mind. It is your best option.

These are essential features eQMS should contain:

  1. Document control with versioning, history, statue, and e-signatures
  2. Workflows, Procedures, SOPs, and Processes support – Processes should drive the workflow so users don’t have to, and users cannot ignore.
  3. QMS progress overview of the various stages and steps in QMS workflow processes
  4. CAPA tracking system, showing what needed to be fixed, who was assigned to fix it, and what was fixed and support for Risk assessments conformant with ISO 14971

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An eQMS must be dynamic, and capable of being analyzed and changed quickly. A real-time managed system stored and managed electronically provides speed and agility to any organization. It permits management to communicate continually so that the quality message is heard regularly but also delivers procedures, processes, and instructive material to everyone in the organization.

It may seem that a paper-based QMS is cheap to maintain. However, there is a huge amount of hidden costs due to the enormous amount of time the organization spends to ensure the ongoing management of such a system. With an eQMS, you cut down costs in the long run.

An eQMS system when properly implemented of course can be easier to maintain, all the information is immediately available at any workstation, it is easily audited, and any changes are easily communicated across the organization.

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8 replies to “Conclusion – it doesn’t have to hurt if you chose right!”

  1. Kyle McCarthy says:

    Hi everyone! I know I might be late to join the discussion, but still, have urge to share that recently qmsWrapper released their update. To be honest we were using Qualio. Qualio did satisfy our needs, but from curiosity, we did a demo with qmsWrapper, and wow! Sounds weird, but it’s a new year, it’s time for new resolutions, and we decided to transfer to wrapper.

  2. Kristen F. says:

    Backing to this discussion – thank you all. I’m on the free trial and testing qmsWrapper. It’s quite solid. I’m amazed I can create my own workflows. Default ones helped as well. Especially like “approved” marks for files. 🙂

  3. . says:

    This site was… how do you say it? Relevant!! Finally I have found something that helped
    me. Thanks a lot!

  4. . says:

    Do you have any video of that? I’d love to find out more details.

  5. Kristen F. says:

    Thank you for your suggestions. I’ll check this solution. I never heard about them.

  6. Louis W says:

    I am working in the medical device manufacturing industry, a couple of times we struggle as we couldn´t cover all our needs with the software we had. I don´t remember exactly which ones were the ones we were using but maybe something similar to what Ben just shared. They cost a fortune and in the end, we had issues during audits and in general with the organization. Now the last couple of years we´ve been using QMSwrapper, it is an easy to use, affordable and very complete system that assist us in succeeding in our CE Mark certification. It doesn´t cost a lot, it is a very affordable annual membership and one of the greatest benefits is that is multiuser. Recently they added new updates that WOW all our team.

    Hope it helps

  7. Ben Bohn says:

    Hello Kristien,

    That is true, some software like this is pricey but I was checking the price for QMS Wrapper software and the price is only around $1000. If you compare to similar software like Green Guru the price for that software is $10000 and that is a lot. But QMS Wrapper has an affordable price and the same features as the Green Guru. And when you add the price of paper and printing inc the amount piles up and quickly you reach that $1000 price range. So when someone says that the price is high, plus the time you save when you need to find a certain document. That dear Kristian is priceless especially when you being audited.

  8. Kristen F. says:

    QMS software with such characteristics will cost the fortune. To start-up, each $ counts. We chose to remain paper-based.

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