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eQMS is Like a Chocolate Selection box: Choosing the Right Quality Management System

Choosing an electronic Quality Management System (eQMS) might not sound like it has much in common with picking out a chocolate bar, but in many ways, the process is surprisingly similar. Both involve sifting through a variety of options to find the perfect fit for your specific needs and tastes. Just like when you’re deciding between dark, milk, or white chocolate, selecting the right eQMS requires considering your unique preferences, goals, and requirements.

Do you prioritize smoothness and simplicity, or do you need something with a bit more complexity and richness? In this blog, we’ll explore how the decision-making process for an eQMS mirrors the sweet (and sometimes overwhelming) experience of choosing your favourite chocolate bar. So, let’s unwrap the similarities and help you make a decision that’s both satisfying and beneficial

The eQMS Landscape

Here’s an interesting fact, just like chocolate, there are over 100 different versions of eQMS software available today! The remarkable thing is that you can build a compliant quality management system with any of these tools. You could even create one using basic platforms like SharePoint or Google Drive!

What Makes the Difference?

So what separates one eQMS from another? Different systems offer varying functionalities:

  • Some leverage AI (artificial intelligence) capabilities
  • Others focus on simplicity
  • Many interconnect with other business functions

It’s all about understanding what’s right for you and your organization. Quality management system software provides both a tool and a framework to build your QMS around. The work and effort required to build a QMS is largely driven by your specific company needs.

The Value of Expertise

This is where consultants become valuable. Through their careers, consultants experience different types of QMS systems built by different organisations at various stages of development. We can help you determine not only where to begin but also where you may want to go in the future. Our perspective and expertise can support you in developing a long-term strategy for quality planning and QMS implementation.

Our Recommended Options

While hundreds of options exist, here are three QMS software providers we regularly work with:

  1. Cognidox  – This is the system we use to build our own ISO-compliant QMS. It offers simple setup, ease of use, and scalability based on your company’s needs rather than forcing you into a predefined structure.
  2. TraceX – A robust alternative with its own strengths and considerations.
  3. ISMS – Another effective system that works well for certain organizational needs.

Both TraceX and ISMS work excellently, each with positives and negatives. The key is understanding what’s important to you, and we’d be happy to spend time with you to discuss these points. What works wonders for one organisation might not be suitable—or even detrimental—for another. This largely depends on each organisation’s unique needs, processes, and goals – just like how someone absolutely adores a coconut Bounty, whereas someone else, not so much!

Finding Your Perfect Match

Sometimes you want a Bounty, sometimes a Snickers, and sometimes you’re not even sure what you’re craving. But what you don’t want to do is settle for something medicore.

For more information on what’s right for you and how to effectively build a quality management system, get in touch with us on [email protected]. We can discuss these processes in more detail and help build you an effective, right-first-time quality management system tailored to your needs, after all, we maintain and work within our own QMS and know that a quality management system is for life, not just for your audits!

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The AI Airlock Programme – The Potential of AI in Healthcare

The Potential of Artificial Intelligence in Healthcare

Artificial Intelligence (AI) in healthcare has the potential to improve patient outcomes, for example, by improving diagnosis or treatment selection. However, it is difficult to assess new and innovative AI technology using traditional trial techniques.

The AI Airlock

In Oct 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that they would set up a regulatory sandbox, the AI Airlock. This will provide software and AI medical device developers with virtual testing environments in which they can design and implement test protocols for their devices. There will be three different testing environments (Simulation airlock, Virtual airlock and Real-world airlock) and different factors will determine which testing environment will be most appropriate to each candidate and their device. MHRA’s AI Airlock webinar, presented in July 2024, provides more details about the AI Airlock.

By bringing together expertise from innovators, regulatory organisations including Approved Bodies, Government, the NHS and academia, the AI Airlock pilot program will allow for a collaborative approach. This will enable developers to generate robust evidence for their technology and assist in safe development and deployment of such devices.

Devices will need to meet one or more of the following eligibility criteria:

  • Has the potential to deliver benefits for patients
  • Device or concept application is innovative
  • Presents a regulatory challenge
  • Device is conceptually/developmental robust and ready to be trialled.

Four to six candidates will be recruited to join the pilot cohort and there is no fee for application or participation in the pilot program. Candidates will need to commit resource to the pilot program and are expected to fund their own studies and delivery of any Airlock testing, including accessing relevant data sets. Whilst this pilot phase of the AI Airlock will run until April 2025, candidates should expect to complete their individual Airlock testing within 6 months.

Learnings from this first pilot programme will inform future Airlock phases and the outputs will include:

  • Project Reports from each candidate project team,
  • An Airlock Sandbox report of learnings to inform future guidance and implications for the regulatory framework,
  • A programme evaluation report sharing learnings on the use of regulatory sandboxes. 

Application to the MHRA

This is a great chance for software and AI medical device developers to obtain advice from regulators whilst they experiment and testing their device in controlled and safe environments. Participation in the programme also offers developers an opportunity to have a part in informing the future GB regulatory framework on software and AI medical devices.   

Candidates can now apply to the MHRA to join the AI Airlock pilot program by completing the application form and returning it to [email protected]  before 07 October 2024.

If you’re looking at developing an AI product, or any other diagnostic device, please do get in touch as we can support you from idea to design and market – you can contact us here for a complimentary introduction chat

Written by Tsz Wai Woo, Regulatory specialist at IVDeology