Qualio or Qualityze? eQMS comparison

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


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

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


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


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


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

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


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


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

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	Integration with Salesforce only (built on Salesforce platform)

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 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


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