Qualio or Qualtrax? eQMS comparison

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

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

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


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


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


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


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


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


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

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

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	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

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