Qualio or Qualtrax?

A balanced eQMS comparison to help you make the right choice




See why our customers prefer us

The lowdown


  • Founded 2012

  • 500+ customers

  • Cloud-based eQMS with integrated, configurable system areas

  • Designed for SMEs

  • Life science focus

  • Wholly independent with singular product roadmap
Qualtrax logo

  • Founded 1993

  • 300+ customers

  • Modular on-premise or cloud-based compliance software

  • No company size focus

  • Primary lab focus - also used in energy, aerospace and more

  • Acquired by Ideagen in 2021; now part of a 19-product suite

Features, functionality and usage

Document management

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  • Cloud-based document library with complete lifecycle control 

  • Part 11 and EU Annex 11 e-signatures

  • Version control and GDocP baked in at all times


  • Cloud-based document library with complete lifecycle control 

  • Part 11 and EU Annex 11 e-signatures

  • Lack of in-system editability means documents must be downloaded, edited and re-uploaded

  • Potential version control and integrity weaknesses if not used correctly

Training management


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  • Train users and user groups on system documents with e-signatures, reminders and configurable quizzes

  • At-a-glance visibility and reporting of training metrics, like outstanding and completed training

  • Assign role-based training to users with reminders, tests and full system recording

  • Training matrix can be used to identify gaps

Quality event management

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  • Single system area for managing all quality processes

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

  • Map your processes into the system for consistent, easy-to-follow work

  • API integration to pull and resolve CRM customer issues straight from Salesforce

  • 'Process management' module can be used to configure workflows for quality events like CAPAs and incidents

  • Some fixed workflows for events like internal audits, vendor approval and management review

  • Some customer reports of difficulty configuring workflows and an 'intimidating' interface

  • Some ERP integration functionality to populate workflows

Design controls

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  • Dedicated Design Controls functionality for medical device organizations

  • Provides full control/traceability of design elements to bring a medical device to market

  • Pulls design elements automatically from your other testing systems like Jira, Azure DevOps, Asana, Zephyr, Xray or TestRail

  • None

Supplier management

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

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

  • No specific supplier management area; some manual workarounds could be available with process workflows

Ease of use

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

  • Clean, minimal UX in a cloud-based system to maximize user engagement and simplify training and onboarding

  • Consistently ranked the easiest eQMS software to set up and use
  • Older and less intuitive user interface with multiple layers and branches

  • Some areas of the system reported as difficult to use by customers - particularly workflow, reporting and dashboard areas. Multiple requests for more help resources

  • Document, training and process focus of the system makes application for other quality management areas clunky and manual

Implementation & validation

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

  • Standardized validation for all customers

  • Industry-leading implementation timeframe: 60-day target

  • Still follows outdated IQ- and OQ-based validation process which adds unnecessary complexity and work

  • Split offering across 4 validation tiers: extra fees for annual upgrades, validation risk assessments and IQ/OQ reporting


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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

  • Only limited integrations with Word, Excel, Active Directory and some ERPs available


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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

  • Tight focus on life science start-ups and scale-ups makes scalability and growth a central system component

  • Tight focus on document, training and process management makes general scaling up of a holistic quality system more difficult

  • Reported configurability difficulties for some system areas may harm engagement and long-term scalability potential

  • Broad company size focus makes scalability a less integral part of the product

Customer focus

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  • Commits to a long-term partnership with customers: voted best support on G2. 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 make you an expert and accelerate compliance

  • Strong life science focus makes Qualio's product and support highly specialized for the industry

  • High marks from customers for strength of support and willingness to fix issues. Customer portal available to contact Qualtrax team

  • Software only: no life science system content or expert QA/RA support

  • No real industry focus within the product: some life science customers, but also aerospace, manufacturing and energy. Limited in-house expertise for industry guidance

Choose Qualio if you:

  • Are a life science company and want an eQMS designed to match your industry

  • Need design control and supplier management functionality

  • Want to build a collaborative culture of quality

  • Want a widely-used and highly reputable industry tool supported by templated content and QA expertise

Choose Qualtrax if you:

  • Aren't a life science company

  • Only need document, training and process management

  • Don't need to integrate your eQMS with your other business tools

  • Want the option of an on-premise system from a well-regarded vendor