Qualio or Greenlight Guru?

A balanced eQMS comparison to help you make the right choice

The lowdown

Document management


Managed with in-system editing of configurable document templates Version control and GDocP baked in as standard Unlimited free basic users	Managed with attachments that are uploaded into the system. Lack of in-system editability means documents must be downloaded, edited and re-uploaded Potential version control and integrity weaknesses if not used correctly All users chargeable, even 'lite' users

Training management


Integral functionality built in tandem with Documents for close linkage and easy, intuitive use	Newer functionality added in 2020. Not as polished as wider system, but could cover your basic training needs

Quality event management


Fully configurable workflows for managing any kind of quality event: complaints, CAPAs, change control, deviations	Fixed, unchangeable 5-step workflows for all core quality management activity. Limited ability to evolve processes

Design controls


Newer functionality added in 2020 Not as polished as wider system yet, but provides all design traceability and elements for easy collation of Design History File Ecosystem focus means the system pulls design elements automatically from your other testing systems like Jira, Azure DevOps, Asana, Zephyr, Xray or TestRail	Core, original component of the product due to medical device focus Design History File automatically generated Only light, manual connection with Jira involves URL copy and paste, rather than true API integration

Supplier management


Build a configurable database of your supply chain in a dedicated supplier management area Set bespoke policies for manufacturers, service providers, distributors, consultants and more – then use them to enforce supplier requirements and ensure compliance Attach key documents as required	No dedicated supplier management area; manual workarounds in document and audit management areas required Customer reviews mention having to go through Greenlight Guru support to add and change supplier records

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	Designed to be aesthetically eye-catching with a ‘bells and whistles’ approach The Visualize functionality, available in the most expensive software package, provides a helpful visual linkage of design artifacts which is useful for medical device auditors Overall system regarded as slightly more complicated and difficult to learn than Qualio

Implementation & validation

Follows 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
Balance of fixity and configurability within a GAMP Category 4 system
Average implementation time frame: 60 days

Still follows older computerized system validation (CSV) formula, with outdated time-consuming documents like IQs, OQs and PQs provided for customers
New validation pack issued for each major product update
GAMP Category 3 system means theoretically simpler validation, but this is negated by older validation approach
Average implementation time frame: 90 days

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Reported customer implementation timeframes on G2

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 API integrations with Salesforce, Jira, Zephyr, Xray, Azure DevOps, Asana, TestRail and ComplianceWire, with NetSuite integration on the way	Designed to keep your teams within Greenlight Guru. Light integration with Jira only

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	Designed to arm your business with a fixed eQMS that embeds repeatable, unchanging processes Less scalable by design

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	Offers product support, dedicated customer success managers, and Guru Assist, advisory and strategy sessions Greenlight Guru Academy offers on-demand courses for medical device quality and regulatory topics

Aren’t a hardware medical device start-up
Are a hardware medical device start-up but favor a flexible, long-term quality approach
Have existing processes you want to digitize and automate
Want to work with a company with fewer, happier customers

Are a medical device hardware start-up and want a fixed quality approach
Don’t want to change your processes in future
Want to comply with your regulatory requirements with a rigid, set structure
Want to work with a company with more customers and a more established market presence