Overview

Cognidox is a cloud-based lean eQMS and document management system designed to support regulated industries like medical devices, biotech, and high tech. It offers configurable workflows, design controls, e-signatures, training management, and compliance tools for standards such as ISO 13485 and FDA 21 CFR Part 11.

Updated Sep 24, 2026.

Key Features

Pros

Configurable and scalable to support from small teams to large enterprises with 2000+ users.
Supports compliance with multiple regulatory standards including FDA 21 CFR Part 11, ISO 13485, MDSAP, and GxP requirements.
Integrated e-signatures and audit trails enhance regulatory audit readiness.
Includes a built-in Learning Management System to manage training and assessments.
Flexible design controls and phase gating support complex product development workflows.

Cons

Pricing details beyond the free Starter plan require direct contact and are not fully transparent online.
Primarily focused on regulated industries, may be less suitable for non-regulated sectors.
No explicit mention of mobile app availability or offline access.
Implementation and onboarding may require dedicated support and configuration.
Limited public information on integrations beyond DocuSign and API availability.

Pricing

cognidox pricing plans
Plan	Price	Highlights
Starter Year	Free	5 User Limit Core document management MS Office Plugin (Cross platform) Limited Access Partners Private Workspaces Standard Support
Growth	Contact Sales	30 User Limit Everything in Starter Expanded user capacity E-Signatures & manifests 500-doc migration free
Scale	Contact Sales	50 User Limit Everything in Growth Expanded user capacity DocuSign integration Learning Management System API Integration
Pro	Contact Sales	100 User Limit Everything in Scale Advanced user capacity Dedicated account management Extranet
Enterprise	Contact Sales	Custom User Limit Everything in Pro Enterprise Programme Disaster Recovery Virtual Machine (DVRM)

Pricing is collected from the official cognidox website and may change. Always confirm with the vendor.

Key Features

Pros

Configurable and scalable to support from small teams to large enterprises with 2000+ users.
Supports compliance with multiple regulatory standards including FDA 21 CFR Part 11, ISO 13485, MDSAP, and GxP requirements.
Integrated e-signatures and audit trails enhance regulatory audit readiness.
Includes a built-in Learning Management System to manage training and assessments.
Flexible design controls and phase gating support complex product development workflows.

Cons

Pricing details beyond the free Starter plan require direct contact and are not fully transparent online.
Primarily focused on regulated industries, may be less suitable for non-regulated sectors.
No explicit mention of mobile app availability or offline access.
Implementation and onboarding may require dedicated support and configuration.
Limited public information on integrations beyond DocuSign and API availability.

Pricing

cognidox pricing plans
Plan	Price	Highlights
Starter Year	Free	5 User Limit Core document management MS Office Plugin (Cross platform) Limited Access Partners Private Workspaces Standard Support
Growth	Contact Sales	30 User Limit Everything in Starter Expanded user capacity E-Signatures & manifests 500-doc migration free
Scale	Contact Sales	50 User Limit Everything in Growth Expanded user capacity DocuSign integration Learning Management System API Integration
Pro	Contact Sales	100 User Limit Everything in Scale Advanced user capacity Dedicated account management Extranet
Enterprise	Contact Sales	Custom User Limit Everything in Pro Enterprise Programme Disaster Recovery Virtual Machine (DVRM)