Qualio or Cognidox?

A balanced eQMS comparison to help you decide



Cognidox screen


See why our customers prefer us

The lowdown


  • Holistic, integrated eQMS

  • Founded 2012

  • 500+ customers

  • Cloud-based, paperless, market-tested eQMS

  • Supports/simplifies quality and compliance

  • Designed for SMEs

  • Life science focus


  • Modular eQMS

  • Founded 2008

  • 100+ customers

  • Cloud-based, paperless, market-tested eQMS

  • Supports/simplifies quality and compliance

  • Designed for scale-ups

  • Medical device/high-tech product focus

Features, functionality and usage

Document management

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  • Cloud-based document library with e-signatures, native editing, tagging and templates

  • Documents edited and collaborated on within the system


  • Workflow, review and control functionality


  • As the name suggests, originally built as a document tool. Now a cloud-based structure for storing and managing documentation with forms and templates

  • 'Shared notes' functionality for collaboration, but Office integration means documents must be edited there, then updated in the system. Some customer reports of difficulties with PDF conversion, formatting of document properties in Office, and collaboration on early-stage documents

  • Workflow, review and control functionality

  • DocuSign add-on for extra e-signature functionality

Training management

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  • Train users on eQMS documents and house training records in a digital repository

  • Train users on eQMS documents and house training records in a digital repository

Quality event management

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  • Fully configurable workflows in a single area for managing any kind of quality event: complaints, CAPAs, change control, deviations, etc.

  • Editable form templates allow bespoke information capture and response within a scalable, malleable eQMS

  • Separate form-based modules for management of CAPAs/NCRs and change control

  • Largely static templates with limited configuration

  • Some customers report inability to tweak workflows because of fixed steps

Design controls

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  • Dedicated design control area centralizes and manages all medical device design elements for easy collation of Design History File: ISO 14971 and FMEA risk management, user requirements, open device issues, etc.

  • Pulls design elements automatically from your other testing systems like Jira, Azure DevOps, Asana, Zephyr, Xray or TestRail with plug-and-play API integrations

  • Design control module offers 'gate' structure that encourages collection of appropriate design documents for each stage

  • More for coordinating deliverables than managing and controlling device risks within the system

  • Integrates with CAD, PCB, development and PLM tools

Supplier management

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  • Build a configurable database of your supply chain in a dedicated supplier management area

  • Set bespoke policies for manufacturers, service providers, distributors, consultants and more – then use them to enforce supplier requirements and ensure compliance

  • Attach key documents, manage audit details and export Approved Supplier Lists (ASLs) as required

  • Supplier module allows scorecards and connected workflows to evaluate, onboard and monitor suppliers

  • Store supplier-related policies and procedures

Audit management

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  • Quality event forms and workflows can be configured to capture and respond to audit data

  • Intuitive system UX and visible metrics make it easy to pinpoint weaknesses and demonstrate compliance to external auditors

  • CAPA/NCR templates in module can be used to capture and respond to audit data

  • No other audit functionality


Equipment management

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  • Quality event forms can be configured to capture and respond to equipment and asset data

  • CAPA/NCR templates in module could be used to capture and respond to equipment and asset data



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  • Rich analytic dashboards for at-a-glance visibility of document, training, event and supplier management activity

  • Dive into visual eQMS data to spot trends, fix bottlenecks and more

  • Colour-coded training dashboards for visibility of training status

  • No other analytics; graphical business management system (BMS) dashboard does allow visual depiction of internal processes


Ease of use

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  • Designed with natural, intuitive ease of use at the core

  • Clean, minimal UX to maximize user engagement and simplify training and onboarding

  • Consistently ranked the easiest eQMS software to set up and use

  • Designed primarily as a document repository - some customer reports of dated UX and steep learning curve at initial use

  • Siloed modular set-up and limited analytics could make cross-system traceability more difficult

Implementation & validation

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  • Industry supplier guided by the latest FDA and GAMP computerized system assurance (CSA) guidelines for a rapid, least burdensome validation approach for customers

  • Validation document pack provides all objective functional evidence of system suitability. Customers need only perform extra software testing if they feel it’s risk-appropriate

  • Average implementation time frame: 60 days

  • Uses outdated IQ- and PQ-based validation pack now superseded by latest best practice - and not provided to some customer tiers

  • Implementation timeframe unknown 


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  • Designed to seamlessly connect to your other business-critical tools. Keeps your teams in their familiar, specialized systems while the eQMS absorbs real-time data from them

  • Plug-and-play API integrations with Salesforce, Jira, Zephyr, Xray, Azure DevOps, Asana, TestRail and ComplianceWire, with NetSuite integration on the way

  • Office integration for document editing and updates

  • Integrations with CAD, CMS, SCM and EDA tools, as well as Salesforce


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  • Designed to ‘grow with you’ and guide your business up the quality maturity curve to marketization and beyond

  • Flexible, configurable make-up makes tweaking processes, adding new users and scaling up the eQMS quick and easy

  • Unlimited free basic document and training access turns Qualio into a business-wide quality tool

  • Designed for more established companies already above 20 heads

  • Less modern UI may impede wider adoption, more fixed structure could affect long-term scalability

  • Modular structure could allow expansion into new system areas as required

Customer support

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  • Commits to a long-term partnership with customers. Customer success managers, plus high-touch 24/7 support from team members in the US and EMEA with live chat and Help Center

  • Qualio+ package provides targeted QA expert support and pre-built standard-specific system templates to accelerate compliance

  • High marks from customers for responsiveness, level of support, and general satisfaction

  • Product and technical support from UK office

  • No pre-built QMS documentation templates provided, no additional quality and compliance support

  • High marks from customers for quick, responsive support

Choose Qualio if you:

  • Need a holistic life science eQMS with broader functionality for medical device, therapeutic or contract research/manufacturing requirements

  • Want a flexible, scalable system that grows with you and is built for ease of use

  • Need integrations with device design tools to pull design control data into your eQMS

  • Need expert quality and compliance guidance as well as pre-built eQMS document templates

Choose Cognidox if you:

  • Want a 'lean eQMS' serving primarily as a medical device document repository

  • Want a more fixed, modular eQMS for managing documents

  • Need integrations with technical product development systems like CAD and EDA tools

  • Want a graphic business management system diagram to visualize processes