Qualio or roXtra? eQMS comparison

The lowdown

Holistic, integrated eQMS
Founded 2012
500+ customers
Cloud-based, paperless eQMS
Supports/simplifies quality and compliance
Designed for SMEs
Life science focus

Modular eQMS platform
Founded 2001
1000+ customers
Paperless cloud-based quality platform
Supports/simplifies quality and compliance
Designed for SMEs
No industry focus

Features, functionality and usage

Document management


Cloud-based document library with e-signatures, native editing, tagging, templates and review/control workflows Documents edited and collaborated on within the system White-glove onboarding service for easy migration of your old document stack	Document control module allows storage and categorization of documents with all expected control and e-signature functionality No native editing or collaboration - forcing check in and out No 'read and sign' or training functionality Separate Contracts module with prompts and reminders for contract actions

Training management


Train users on eQMS documents and house training records in a digital repository Assessments test understanding and prove operational compliance Build and cascade Training Plans for proactive team training	No training or document sign-off functionality

Quality event management


Fully configurable workflows in a single area for managing any kind of quality event: complaints, CAPAs, change control, deviations, etc. Editable form templates allow bespoke information capture and response within a scalable, malleable eQMS	Separate 'Processes' and 'Actions' modules for designing processes and tracking actions Flowchart Designer allows configuration of workflows

Design controls


Dedicated design control area centralizes and manages all medical device design elements for easy collation of Design History File: ISO 14971 and FMEA risk management, user requirements, open device issues, etc. Pulls design elements automatically from your other testing systems like Jira, Azure DevOps, Asana, Zephyr, Xray or TestRail with plug-and-play API integrations	None - not a dedicated medical device tool Risks module could be used as a partial workaround to record and treat device and design risks

Supplier management


Build a configurable database of your supply chain in a dedicated supplier management area Set bespoke risk 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	None

Audit management

Quality event forms and workflows can be configured to capture and respond to audit data
Intuitive system UX and visible metrics make it easy to pinpoint weaknesses and demonstrate compliance to external auditors

Dedicated Audits module for designing, executing and following up on audits
Some analytics dashboards for preparing for external audits

Analytics


Rich analytic dashboards for at-a-glance visibility of document, training, event and supplier management activity Dive into visual eQMS data to spot trends, fix bottlenecks and more	Analytic dashboards with configurable filters and formats to view system data

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	Slightly dated but generally clean and simple UX Modular set-up could impede usability in some areas No customer reviews to understand real experiences

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	GxP validation offered, but with outdated IQ-, OQ- and PQ-based methodology Modular set-up would mean extra validation tasks as new modules are added Set-up time unknown

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	No integration information 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 eQMS quick and easy	Modular structure could allow expansion into new system areas as required, but with additional user costs

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	Basic Support Center with ticketing or Germany-based telephone services No pre-built QMS documentation available No public customer reviews to gauge sentiment; customer base almost entirely in Germany

Choose Qualio if you:

Want a dedicated life science eQMS with design control, training and supplier management functionality
Need industry-specific support and pre-built documentation
Want a scalable eQMS that grows with you and integrates with your other tools
Want a system backed by real customer reviews and international customer support

Choose roXtra if you:

Don't need a specific life science quality tool
Want a dedicated audit management module
Want a modular system to add on new elements as you go
Want German-language support