Qualio or Qualityze?

A balanced eQMS comparison to help you decide





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 16-sectioned eQMS

  • Founded 2015

  • 300+ customers

  • Cloud-based, paperless, market-tested eQMS

  • Supports/simplifies quality and compliance

  • No customer size focus

  • No industry focus

Features, functionality and usage

Document management

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

  • Version control and GDocP baked in as standard
  • Cloud-based document library with e-signatures and templates

  • Lack of native editor means documents must be downloaded, edited and re-uploaded

  • Potential integrity and version control weaknesses if used incorrectly

Training management


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

  • Push document- or instructor-based training to users and view training records


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.

  • Separate fixed modules for CAPA, NCR, complaint, change and incident management

  • Forms module could be used to manually configure detail capture for other event types, but no workflow functionality for response to these event types

Design controls

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  • Centralizes and manages all medical device design elements for easy collation of Design History File

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

  • No dedicated design control functionality

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 quality management module offers supplier library with qualification and scorecard functionality

  • No functionality for enforcing supplier quality and compliance policies, but supplier audits can be scheduled and managed in the module

Equipment management

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  • No dedicated maintenance/calibration functionality, but quality event forms can be configured to capture and respond to equipment and asset data

  • Dedicated maintenance and calibration modules for equipment logging and upkeep


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

  • Dated UI may be less intuitive to use

  • Siloed modular set-up makes cross-system traceability more difficult

  • Limited configuration and fixed structure makes long-term malleability 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-, OQ- and PQ-based validation now superseded by latest best practice

  • Manual 'test/validate' phase may not use modern automated structure used by Qualio and other eQMS vendors

  • Complex, 16-module structure requires more testing and validation work, resulting in a longer implementation timeframe based on your package complexity


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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

  • Integration with Salesforce only (built on Salesforce platform)


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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 QMS quick and easy

  • Modular, inflexible set-up impedes scalability

  • Less intuitive UI may impede wider adoption and long-term scalability

  • Modular pricing may be cost-prohibitive for companies wanting to expand into new system areas

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

  • Offers product and technical support

  • Large workforce presence in India; less domestic support for US customers

  • No QA support or QMS documentation templates provided

Choose Qualio if you:

  • Are a life science company

  • Want a single, integrated eQMS with all required functionality

  • Want a flexible, scalable system that grows with you

  • Want your eQMS to integrate with multiple other business-critical tools

Choose Qualityze if you:

  • Aren't a life science company

  • Need equipment maintenance/calibration, mineral, permit and field safety modules

  • Want a fixed, modular eQMS structure

  • Only want eQMS integration with Salesforce