Qualio or QT9? eQMS comparison

The lowdown

Founded 2012
500+ customers
Cloud-based eQMS with integrated, configurable system areas
Designed for SMEs
Life science focus

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

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


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

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

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


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


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


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


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

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	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

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 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

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