Qualio or Cognidox? eQMS comparison

The lowdown

Document management

Cloud-based document library with e-signatures, native editing, tagging and templates
Documents edited and collaborated on within the system

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


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


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


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


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

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

Equipment management

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

Analytics

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


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


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

Ecosystem


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

Scalability


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


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

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

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