Why not just use Qualio as your medical device eQMS?

Qualio is an eQMS platform launched in 2012 by Irish entrepreneur Robert Fenton. From small beginnings, his company is now headquartered in San Francisco and Dublin. 

It has more than 500 clients worldwide, working across the medical device, pharma, biotech, and contract manufacturing markets.

Qualio's stated mission is to break down the silos of development, manufacturing, and quality, helping life-science companies collaborate more effectively, scaling their operations and speeding the passage of lifesaving products to market. The company grew significantly during the Covid crisis, securing $50 million in funding in 2021.

What's so great about Qualio?

There are great features that make Qualio the successful and popular package it is today. The interface is clean and easy to use. The company's focus on deep integration is attractive for developers who often find themselves working in silos using different platforms and apps. 

The integration options with development software such as Jira makes for frictionless design control. Qualio helps you automatically track and manage the production of required design inputs and outputs within your QMS. It means you don't have to retrospectively pull together evidence from different platforms for your DHF (Design History File) and DMR (Device Master Record). Instead, it's collated and stored in real-time as you work. 

For companies developing complex medical products, having your requirement, risk and change management all integrated into one document control system helps keep the entire team focused on quality, reducing mistakes and increasing your velocity. 

Some reviews speak of navigation issues

But while there is praise for these features, some users express frustration about the way information and data is indexed and retrieved in the Qualio system. As a contributor to G2 (the software review website) puts it:   

"There is a total lack of document structure or inventory for ease of navigation. Can't effectively search for things if I don't know the title, tag or ID." 

The Qualio system does not have a category structure of files and folders, meaning you can't easily browse the system without having a specific document in mind. You can't see your files and folders laid out in a root and branch format, giving you a vision of your QMS’s structure, as well as potential absences and omissions. And as mentioned above, this makes it difficult to find something quickly when you can't remember how you originally tagged it. 

Another way the navigation is frustrating in the Qualio system is how it treats records as events that all go into a single pot. Because of this, it's impossible to go to a specific area of the platform to see particular types of records. Instead, you need to apply filters to see the information you need, and there are limited options to change how it is presented. This can make it hard to locate records and organise reporting in a way that suits you. 

How does Qualio work?

One of the most striking aspects of configuring this system is that it requires you to create your quality documents in the 'Qualio format' rather than with the familiar tools of Microsoft that most teams use every day. In Qualio, documents are displayed as web pages and can be edited only within these windows.  

This has some advantages. It ensures editing and collaboration can only happen in one place. It means documents can't be changed without authority, and every change is instantly updated in the audit trail. 

Some customers speak about their frustrations with this on G2:

 "The text editor can be difficult to use, especially to preserve formatting for more complex documents."

 "It's challenging to create documents with Qualio." 

This feature presents significant challenges for companies as they configure their quality systems. It could take a long time for those who are already midway in their development to migrate existing content from their Word and Excel documents and reformat them within Qualio. This surely adds unnecessary risk and complexity to a roll out process.

 Not only this, but if you choose an eQMS that is overly complicated with its own unique formatting and operating system there’s a danger that it will become the preserve of the quality department alone. Your employees may simply vote with their feet and choose more familiar places to work and collaborate instead, via systems such as G-Suite and One Drive.

Another unwelcome effect of this walled garden approach is to 'lock in' companies to use Qualio in the future.  When migration is so difficult it'll be a real effort to move away, whatever direction they decide to take with the software and whatever they choose to charge. 

Speaking of which:

How much will Qualio cost you?

Qualio has a four-tiered price structure supporting different stages of business development: 

• Start-up - from approx. $12K p.a.
• Growth – from approx. $20K p.a. with compulsory onboarding costs
• Growth Plus – from approx. $30K p.a. with compulsory onboarding costs
• Enterprise - Bespoke

The start-up package offers restricted access to the platform. But as it does not even track quality events, it is not really suitable for a scaling medical device company.

The Growth package offers customers full access to the platform with log-ins for ten users.

The Growth Plus package includes pre-configured templates and forms, plus advisory support for ISO and FDA compliance. But no matter what package you choose, adding additional users over the included ten will cost you approx. $300-350 pa each, depending on the deal offered.

Both Growth packages also entail a minimum three-year commitment. So, if you want to go for the Growth Plus package, a minimum initial Purchase Order in the region of $100K will be required.

To be fair, requiring a three year commitment matches other eQMS vendors in this sector including Greenlight Guru. A minimum term may be OK if everything goes well, but it's an expensive condition if you find the solution does not work out for you.

Should you choose Growth?

With the Growth package, customers will have to bring their existing SOPs and forms across from their legacy systems and re-engineer them to fit with the way the Qualio software works. But any resulting mismatch between process and software may cause non-conformances to arise. Without advisory support, customers will be taking a lot of risk on their own shoulders as they try to build out their own solution to meet the regulations.

Or Growth Plus?

To reduce this risk others may prefer to go with the Growth Plus package, which comes with advisory support, as well as pre-configured SOPs, forms and other templates. But this means customers may have to change their internal processes and retrain their staff to match the way the software operates.

For those looking to scale fast, having to reconfigure existing process and procedures (that may be working perfectly well) can feel like a massive waste of time and effort. It may serve to slow you down just when you most need to increase your velocity.

Choosing a digital QMS with forms, workflows and SOP templates that are adjustable to match the way you work, can help everyone in your business adopt your solution more quickly. Overtime, they can help you adapt and optimise your procedures to meet commercial and compliance goals more effectively. For those looking to take a LEAN approach to medical device development, these more flexible digital options may make more sense than an eQMS solution that simply demands you work in particular ways to achieve compliance on their terms.

Conclusion

Qualio is a mature business with a successful and popular platform. The company is doing well and has had fresh funding injected during the pandemic that is driving further growth. From now on, it is also donating 1% of its profits to improving healthcare access for vulnerable populations. 

But while the Qualio solution is a powerful, integrated quality management platform the price you pay for this deep integration can be a reduction in flexibility and configurability. Initial set up may be expensive and long winded as you manually import and reformat existing documentation. And you may end up wasting valuable time and resource working with a consultant to change your procedures just to fit the demands of their software.

While some businesses will have the time and resource to devote to this wholesale operational change, others may not. For these companies, there are now more flexible med-tech QMS options on the market which can grow with them and flex with their changing needs.