Qualio or Greenlight Guru?

A balanced eQMS comparison to help you make the right choice

 

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See why our customers prefer us

The lowdown

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  • Flexible, configurable software to match, evolve and scale with you.

    Development philosophy:

    Life science start-ups and scale-ups are constantly maturing and evolving on their route to market. Your eQMS should drive, not block, this impulse

  • Founded 2012

  • 500+ customers

  • Cloud-based, paperless, market-tested eQMS

  • Supports/simplifies quality and compliance

  • Designed for SMEs

  • Life science focus

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  • Prescriptive, highly controlled software with limited configuration.

    Development philosophy:

    Forcing customers to work in a certain way guarantees quality and compliance by eliminating room for error

  • Founded 2013

  • 800+ customers

  • Cloud-based, paperless, market-tested eQMS

  • Supports/simplifies quality and compliance

  • Designed for SMEs

  • Medical device hardware focus

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G2 Momentum Grid® report for quality management (QMS) software | Fall 2022

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Features, functionality and usage

Document management

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  • Managed with in-system editing of configurable document templates


  • Version control and GDocP baked in as standard


  • All users chargeable
  • 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

  • No subscription charge for ‘read only’ users

Training management

 

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

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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

  • 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

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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


  • Designed to arm your business with a fixed eQMS that embeds repeatable, unchanging processes

  • Less scalable by design

 

Customer support

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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 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

 

Choose Qualio if you:


  • 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

Choose Greenlight Guru if you:


  • 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