GxP compliance software for CROs & CMOs

GxP
FDA 21 CFR Part 11 & Annex 11
ISO 13485; 2016
eTMF and IESF

Ditch SharePoint. Automate compliance. Deliver projects faster.

CROs and CMOs need to move fast - but patchworks of SharePoint, Google Drive, and DocuSign aren’t built for regulated environments. Cognidox brings all the tools you need to manage GxP compliance in one platform. It’s the LEAN eQMS that helps you run projects efficiently and manage stress-free audits.

One eQMS for end-to-end document control

Projects slowing down? Scrambling to prove compliance to sponsors and auditors?

Cognidox replaces disconnected G-drives and third-party e-signature software with one integrated system. No more hunting through shared drives. No more workarounds.

Centralised, version-controlled document control
Automated approval workflows - bespoke to you
E-signatures compliant with FDA CFR Part 11 and Annex 11
CAPA, deviation, and risk management modules
Change control and full audit trails for inspection readiness
Traceability across all records and decision-making

Cognidox-Typical-Document-Workflow

Training management built in - not bolted on

Say goodbye to Excel and disconnected learning tools. Cognidox empowers you to deliver and track training as part of your QMS.

Role-specific learning paths across teams and sites
Training courses with SOP-linked videos and quizzes
Automatic assignments when documents are updated
Real-time dashboards and progress tracking
Audit-ready completion reports by user, role, and document

Validation made simple

Cognidox empowers customer-led validation by giving you full control of your processes, while providing the transparency, tools, and guidance needed to validate faster and with confidence.

Purpose-built to support compliance with ISO 13485 and FDA 21 CFR Part 11, the platform is designed to be validation-ready right out of the box—without adding unnecessary overhead to your existing workflows.

Every software release includes comprehensive test documentation and risk templates, ensuring your teams can meet regulatory requirements efficiently and with minimal disruption.

Standard features

Document control

Workflow automation

Training tools

Software validation

Compliant e-signatures

Quality modules

Lean eTMF & eISF management

Build a TMF framework that matches your trial structure — agile, scalable, and affordable.

Agile & scalable: support growing, multi-site trials without enterprise bloat
eISF integration: investigator sites manage their own eISFs securely, synced with sponsor TMF
Compliance built-in: GCP & ALCOA++ with audit trails and e-signatures
Real-time visibility: track all changes and approvals with full decision history

Meet global standards with confidence

Cognidox helps you stay aligned with:

GxP (GMP, GLP, GCP)
ISO 13485:2016
FDA 21 CFR Part 11
EU GMP Annex 11
ICH Q6, Q8, Q9, Q10
GAMP 5

All the support you need - no nasty surprises

With Cognidox, you get everything you need in one platform, with transparent pricing and no hidden extras. Scale smoothly, prove compliance to sponsors and regulators, and keep delivery on track.

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.