Comparing eQMS Solutions: Qualio Vs Cognidox


Cognidox and Qualio are both digital quality management systems (QMS) with a focus on the life science and medical device markets. This blog post explores the strengths and weaknesses of each solution, and what kind of organisation could benefit most from their structure and controls.

Qualio vs Cognidox an overview

Qualio is a powerful and popular eQMS for life science companies. It offers a fully integrated, closed-loop system which requires users to build out documents in its own native format and using its own SOP (Standard Operating Procedure) templates. This ‘all or nothing’ approach to QMS set-up makes for a highly robust quality solution, but can mean a big up-front investment of time and money to get started. It can also require significant internal changes to make your existing processes fit the software.

Cognidox, on the other hand, takes a modular approach to quality management, making it easier for scaling life science companies to migrate from paper-based to digital QMS in ways that make sense for them. The platform allows developers to easily customise templated workflows and create their own forms for quality events to meet the requirements of ISO 13485:2016, but without forcing them to change established ways of working when they don’t have to. Cognidox gives developers the tools to impose governance through document change control, e-signatures and audit histories without slowing down the pace of their development.

Download our guide to digital document control for medical device developers

Here’s how the differences between the two systems can play out as businesses plan and build their digital Quality Management Systems. We’ve also included some anonymised quotes from users and trialists of both systems to give a sense of how they are used in the real-world.


First things first. How much do they cost?

Qualio offers a basic package which covers quality events (e.g. Non-conformances, complaints etc) as well as supplier management features. Even for the basic package, pricing starts at over $20K (excluding compulsory onboarding costs of around $4K). If you want to include templates and regulatory advice you can add another $10K pa to the above starting price. Most deals will also require a multi-year commitment.

Meanwhile, Cognidox is designed to reflect the budgetary needs of fast-scaling companies. You can be onboarded with a fully featured system for under $10K. Cognidox offers clients a three month break clause after the first 12 months.

Quality events handling

Like most eQMS systems Qualio offers templated SOPs (Standard Operating Procedures) to handle things like Non-Conformances, CAPAs, and Engineering Change Control. These SOPs are robust and expertly built, bringing users complete peace of mind around compliance. But because they are intended to function in set ways with different parts of the system, they can be difficult to change or discard if they don’t fit your way of working.

Cognidox SOP templates offer more flexibility - businesses can use or discard the SOP templates as needed. Forms can be built out in exactly the way you want, capturing only the information you need and what the regulation requires. The steps of each process can be customised to reflect the way you already work rather than having to retrain your team to fit in with the requirements of the software.

Creating documents - using ‘native tools’ vs everyday software

As mentioned above, Qualio requires you to set up your quality documentation using their own ‘native document editor’ rather than the Microsoft tools that most businesses are familiar with. This closed-loop approach creates a highly secure and integrated system that some users really appreciate

 “I especially like the in-built editor because as a QA professional, it reduces my headaches associated with staff messing up with document template formatting.”

Feedback from Qualio Customer, G2 Reviews

But it does require a lot of time and resource to configure and learn. You may already have created hundreds of quality documents in Word or Excel formats. Have you really got the capacity to transcribe their contents into a new format? Some have found this demand a step to far:

“The Qualio system pushes you towards 100% template adoption but that’s huge pressure to covert documents into another format. We already have 100+ documents created in Word and Excel that we want to use.”

Feedback from Qualio trialist

Cognidox, on the other hand’ allows you to use the existing Word and Excel quality documents that you have been building over the years, migrating them into a logical, digital structure. This brings governance to the way you work without requiring you to master a whole new suite of formatting tools.

Cognidox offers tight Microsoft integration allowing you to browse, add and create documents all from within the office environment.

"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."

Feedback from Cognidox user

Why not use Greenlight Guru as your eQMS? 

Search features – Qualio relies on tagging

The Qualio system relies on tagging, rather than metadata to power their search function. This means you can't easily browse the system for information without having a specific document in mind. Users routinely report that files are hard to find unless you know the right tags.

In contrast, Cognidox is a metadata based system that also allows you to work in the category structures that your employees are used to. This gives users the best of both worlds, reducing time spent searching for documents as part of their daily admin.

Free trial offers

Qualio offers a limited one-week demo on a preset system, without the opportunity to use your own data. Many find this is not enough to understand how long it will take to transcribe your documentation or work out if your team will be able to adapt to its SOPs.

Cognidox offers a 60 day trial with full support, using real-world data. The team will help you with data migration, access to training videos and a practice area, with full training, and dedicated technical support throughout the trial.

Right-sizing for scaling companies?

Qualio software makes the same demands of you, whether you have 1000 people or just 10 in your organisation. The document templates and SOPs require you to work in the ‘Qualio Way’, which may bring much-needed structure and discipline to your quality system.

On other hand, it may embed protocols and approval processes that far outweigh what is required by the regulation, adding unnecessary layers of bureaucracy to the way you work. It should be noted that auditors are increasingly alive to the risk ‘over-processing’ poses to the clarity and effectiveness of a quality system.

In contrast, Cognidox offers a Leaner approach that can be more readily right-sized to different quality needs. 

With these more flexible controls, you have the potential to build, faster more efficient ways of working that can ensure compliance without slowing you down.

There is no doubt that Qualio is a powerful quality management tool. Users praise its robust compliance capabilities and intuitive interface. But for some organisations, Cognidox may prove, a more flexible and cost-effective foundation for a Leaner compliance approach.

How to build your medical device eQMS

Tags: Quality Management System

Joe Byrne

Written by Joe Byrne

Joe Byrne is the CEO of Cognidox. With a career spanning medical device start-ups and fortune 500 companies, Joe has over 25 years of experience in the medical device and high-tech product development industries. With extensive experience in scaling businesses, process improvement, quality, medical devices and product development, Joe is a regular contributor to the Cognidox DMS Insights blog where he shares expertise on scaling and streamlining the entire product development cycle, empowering enterprises to achieve governance, compliance, and rigour.

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