Is Cognidox an eQMS?

Here’s the truth. Cognidox was never conceived as an eQMS platform, but that’s been the secret of its success in the life science sector.

What is an eQMS?

eQMS (electronic quality management systems) are standalone software solutions designed specifically for companies to manage product quality in safety-critical sectors like automotive, aerospace and pharma. The first eQMS were built for large corporations who needed to co-ordinate quality assurance activities across multiple teams over many years.

Oh… and they had a reputation for being complicated to implement. And they could be eye-wateringly expensive to license and maintain.

Did Cognidox start out life as an eQMS?

Not exactly.

In fact, it was a software spin-off from a semiconductor company. Developers Vittal Aithal and Paul Walsh realised how many companies lacked the digital tools to control their engineering documentation and decided to productise their in-house solution.

Cognidox’s magic combination of flexibility and control led to higher-quality products and greater efficiency. It helped companies bring complex, million-dollar tech products to market faster.

It was nothing short of a LEAN revolution for complex, quality management in the high-tech sector.

Other sectors need a LEAN eQMS

But it seemed there were other industries that could benefit from a LEAN approach in their document control and quality management regimes, too.

In the early 2010s, medical device companies were breaking through with novel technology – but the only formal life-science eQMS available were heavy-duty pharmaceutical solutions.

With limited budgets and resources, these innovating companies needed to find the leanest possible way to handle the regulatory requirements of the EU MDR and the FDA QSR.

Cognidox was the answer

Traditional eQMS solutions often cost the earth, took months to implement, and tied you up in red tape when you most needed the freedom to grow.

In contrast, Cognidox offered developers all the tools they needed for digital compliance with the FDA’s 21 CFR Part 11 and the EU Annex 11. But it also gave them the freedom to work in a way that suited them.

And it still does today - as the platform offers all the modules and quality event management capabilities that you expect from an eQMS.

What makes Cognidox an eQMS? 

What makes Cognidox different?

We’ve always wanted to help companies build their governance capabilities without cramping their innovation.

But the eQMS platforms that once governed life science development were more ‘one size fits all’.

They were made for big corporations who worked in very different ways from the start-ups spinning out of universities.

The entrepreneurial medical device companies who were trying these eQMS for size were often overwhelmed. They’d find the big software providers would sign them up and leave them to their own devices with systems that were way too process-heavy for their agile operations.

Many would retreat from eQMS altogether and stick with their paper-based systems or Google Docs, preventing them from scaling more effectively with digital quality management systems.

Paper and DIY digital systems were never going to help them grow.

How a LEAN eQMS revolution happened with Cognidox

But in 2016, the medical device company Colaesce discovered Cognidox.

They decided to use the Cognidox DMS as the digital framework for their own Quality Management System. From the start, they could see how the LEAN approach to document control adopted by chip developers could be applied to their sector. And they were right.

“There was incredible flexibility in how the system could be set up so that it would meet our specific needs. It meant we didn’t have to completely reconfigure our working practices.”

David Ahern CEO, Coalesce

The road to ISO 13485

Here were all the tools and templates they needed to set up the SOPs that worked for them.

The intuitive interface meant Coalesce could start using the system with minimal training. Teams could rapidly migrate, automate and control their documentation and processes.

They could easily search for what they needed, working faster and smarter as they approached their first ISO 13485 audit.

“We received certification at the first attempt with no minor or major nonconformities. We sailed through the audit process, and I think a lot of that is down to the fact we had adopted Cognidox.”

David Ahern CEO Coalesce

Cognidox - still leading a LEAN revolution in the eQMS space

Hundreds of medical device and other life science developers continue to use Cognidox to control their documentation every day, taking their cutting-edge products from design to launch.

A decade on from the earliest adopters we still see how Cognidox stands out from its competitors.

Its LEAN approach helps reduce over-processing at every stage of the product life cycle, making audit management more straightforward and less stressful.

Watch: Jonathan Wyn-Beer, Senior Quality Manager of Sandoz, explains the secret to stress-free medical device audits with the Cognidox eQMS:

So, is Cognidox an eQMS?

Over the years, Cognidox has become a respected quality management system for the life science industry.

But it remains an eQMS without the traditional price tag or the one-size-fits-all quality templates that others impose. It’s an eQMS with a LEAN approach to document control and quality management pioneered in the semiconductor industry and refined by cutting-edge medical device SMEs.