Document Management for Biotech & Pharma

FDA 21 CFR 11
Quality by Design
ICH Q8, Q9, Q10
GxP

Biotech development can be a long and demanding road.

The Cognidox eQMS is here to help you streamline your innovation process and meet your milestones without the stress. Cognidox gives pioneering start-ups the digital framework they need to unlock long-term commercial success through document control.

Control the paperwork and automate your process

For biotech start-ups, compliance should be seamless and scalable to your specific needs.

Cognidox empowers you to:

Control documents efficiently
Manage changes seamlessly
Automate SOPs effortlessly
Validate requirements quickly
Gate project phases clearly
Maitigate risks proactively

Digitise and automate your control strategy from the start

If you’ve got the required document controls in place from the start, you won’t need to back-solve your compliance process to convince investors and auditors in the future.

Here are all the QMS tools you’ll need to automate and control the end-to-end quality management of your product from the outset. Cognidox helps you record and evidence your entire process - from discovery to clinical research, regulatory approval and post-market surveillance.

Standard features

Document control

Workflow automation

Training tools

Software validation

Compliant e-signatures

Quality modules

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Meet international regulatory requirements and standards

Meet the requirements of ICH Q8, Q9 and Q10; GxP; GAMP; FDA 21 CFR Part 11; EU GMP Annex 11.

All the support you need with no nasty surprises

Cognidox brings together all the tools for business management and compliance in one easy-to-use package. We’ll help you scale seamlessly with our modular approach and transparent pricing.

Ready to transform your biotech development process?

Cognidox is everything you need to digitise and automate your control strategy, ensuring your pharma and biotech products meet the highest quality standards. Discover how Cognidox can help innovate and accelerate the way you work.

A Guide to GxP

From GDocP to GMP: ensuring data integrity and process control for FDA, EMA, and ISO compliance

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See what our customer say!

The software is very intuitive and configurable. The Cognidox team is friendly and approachable, and understands our needs. All in all, a powerful offering.

David Ahern, CEO at Coalesce Product Development

Cognidox is by far the easiest eDMS/eQMS to use and scores with a 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 thrid-party "logic", such as MFiles or alike.

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 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

The search facility sits at the top of the interface at all times and is extremely powerful and quick, and the advanced search facility is excellent.

David Ahern, CEO at Coalesce Product Development

Cognidox is easy to use and simplifies processes! The support and training provided are fantastic.

Julie Errington, Clinical Trials Manager at NCCPG

Cognidox is a very versatile software, pre-configured for many different Quality Management Systems and yet very easy to use and configure.

Fabio, CEO

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.

Prasanna, COO

We trust Cognidox - it is robust, and with a careful setup, it is almost impossible for us to break it inadvertently. Importantly, this helps focus us on value (document content) and less on administrative process. In contrast to some consultants, it is always available, has excellent value, scales with the team and is easy to manage.