Qualio or QT9?

A balanced eQMS comparison to help you make the right choice


QT9 document management

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

QT9 logo

  • Founded 2005

  • 600+ customers

  • Cloud-based eQMS with 23 separate, fixed modules

  • No company size focus

  • No industry focus

Features, functionality and usage

Document management

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  • Cloud-based document library with end-to-end lifecycle control

  • Part 11 and EU Annex 11 e-signatures

  • Version control and GDocP baked in at all times


  • Cloud-based library with master and display copies of each document

  • 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 on the fly with reminders, tests and full system recording

  • Training matrix can be used to identify gaps, but must be printed out

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


  • Separate modules for managing change control, deviations, CAPAs, non-conforming products, risks, management review, projects and safety

  • Fixed in-system processes with limited configurability; backend work required for deep change

  • Some customer reports of difficulty using the system, despite (or perhaps because of) its fixed guardrails

  • No API integration to pull quality events and issues from other systems

Design controls

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  • Dedicated Design Controls functionality added in 2020

  • 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


  • No specific Design Controls module. FMEA, inspection, engineering change order and non-conforming product modules could offer some design control workarounds, but in a disjointed way

Audit management

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

  • Dedicated module for managing audits, including audit schedule and checklists

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

  • Supplier survey, evaluation and web portal modules

  • Survey and score suppliers by granting access to a web-based interface for suppliers to complete

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

  • More typical license model is more expensive, but allows a collaborative culture of quality with simultaneous access for all system users
  • Older and less intuitive user interface

  • Some areas of the system reported as difficult to use by QT9 customers

  • Concurrent license model hampers business usage by forcing users to share logins and wait for other users to finish before logging in

  • Fixed, 23-module structure can make it difficult to use the whole system holistically

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

  • Industry-leading implementation timeframe: 60-day target

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

  • Customers report longer implementation timeframes than Qualio


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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

  • Primary focus is the integration between QT9's QMS and ERP systems

  • Some other ERP integrations available, such as QuickBooks and Sage. None from a quality management perspective


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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

  • Concurrent license structure allows theoretically unlimited users to access QT9 at no extra cost - but not simultaneously

  • Siloed modular structure and reported usability 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. More static system than Qualio

Customer focus

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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 make you an expert and accelerate compliance

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

  • System support available from offices in the US, Ireland and Australia. Training academy and webinars available for extra help

  • Software only: no regulatory content, template documentation or expert QA/RA support

  • No real industry focus within the product: some life science customers, but also aerospace, manufacturing, automotive and food

Choose Qualio if you:

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

  • Need an intuitive, easy-to-use eQMS with high configurability to scale with you

  • 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 QT9 if you:

  • Aren't a life science company

  • Want a fixed, modular platform


  • Have a low eQMS budget and are happy with a concurrent license model

  • Want a joint eQMS-ERP system