Lean eQMS

Digital quality management that's as agile as you are

What if there was an electronic Quality Management System (eQMS) that could be exactly right-sized to your needs?

Cognidox is a Lean eQMS that provides a flexible, digital framework for ISO 9001, ISO 13485 and FDA 21 CFR Part 820 compliance. It offers all the controls, tools and features that you need to store, index and structure your documentation to meet the regulation.

But unlike other eQMS solutions - Cognidox won’t tell you what to do.

A flexible, digital framework for compliance

You won’t need to change the way you work to use Cognidox. You won’t need to use all the templates and SOPs on offer (although, obviously, they are robust and effective as they need to be).

Instead, we help you adopt and adapt the digital processes and procedures that are right for you, creating a fully compliant QMS that does exactly what it needs to.

Compliance workflows configured for you

Document control tools to build required workflows
E-signature integration
Audit history for every document

Cognidox eQMS

Flexible NCR and CAPA forms to match the way you work

Adapt and optimise forms to monitor and prevent quality issues

Corrective and preventive actions
Opportunities for improvement
Complaints
Non-conformances
Change control

Phase gate design controls for your unique project

Not every design project is the same, but you need to impose required design controls to meet the regulation.

Cognidox is a single source of truth for fast and compliant product development.

Use our document holders to set up a repeatable phase-gated development process that exactly matches your needs.

Easily control inputs, requirements and risks to iterate, validated designs and prototypes.

Don't just take our word for it.

The system is flexible and can easily be customised to your organisational needs. The price point makes it an option for small companies that could benefit from an eQMS but do not have the funds to go with the more popular packages.

Linda Garrod, Quality Consultant at Ivdeology

Cognidox is by far the easiest eDMS/eQMS to use and scores with full-equipped access, without the need to buy/install/grant access to different modules. In addition, Cognidox is independent of any file type and does not use third-party "logic", such as MFiles or the like.

Guenter Duerr, Director at Capsero

Cognidox has transformed our QMS by having one easy-to-use system for all our teams to access, and is saving us time with the manual processes of document control and scheduling.

Claire Raeburn, Quality Compliance Manager at Tissue Solutions

The entire process from demo, training and implementation has been wonderful. The acceptance of the tool within the organization was very fast and growing by the week! This is a very versatile product and is simple to use. The workflows are very powerful and helps build compliance to several standards with ease.