Qualio or Grand Avenue?

A balanced eQMS comparison to help you decide





See why our customers prefer us

The lowdown


  • 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


  • 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 2002

  • 100+ customers

  • Cloud-based, paperless, market-tested eQMS

  • Supports/simplifies quality and compliance

  • Designed for SMEs

  • Medical device focus

Features, functionality and usage

Document management

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  • Cloud-based document library with full traceability, e-signatures, native editing, tagging and templates

  • Documents viewed, edited and collaborated on within the system


  • Cloud-based document library with e-signatures and traceability of all document change activity

  • No native editing or even viewing of documents - must be downloaded from the system to view and change

Training management

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  • Train users on eQMS documents and house training records in a digital repository

  • Train users on eQMS documents and house training records in a digital repository

Quality event management

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  • 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 system modules for management of CAPAs, complaints and non-conforming materials

  • Customers report largely static out-of-the-box set-up with limited flexibility and intuitiveness

  • Some modifications only possible by contacting the company directly

Design controls

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  • 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

  • Checklist- and document-based module for building a design history file (DHF)

  • Tabulated checklist allows documents to be manually created for each stage of design lifecycle

  • No native integration with external tools - 'Connector Write' APIs offer theoretical 'pull' integrations from external tools, but with extra work

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, manage audit details and export Approved Supplier Lists (ASLs) as required

  • Supplier module allows recording of approved, exportable supplier list with evaluation form for proposals and updates

  • Link supplier records to audits, CAPAs and non-conformances 

Audit management

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  • Quality event forms and workflows can be configured to capture and respond to audit data

  • Audit module houses templates for audit checklists and summary reports

Equipment management

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  • Quality event forms can be configured to capture and respond to equipment and asset data

  • Equipment management module allows recording of equipment assets and assignment of maintenance/calibration tasks

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

  • UX dated in places and largely table-based

  • Siloed modular set-up makes cross-system traceability more difficult

  • Some customer reviews of unintuitive UX

Implementation & validation

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  • 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

  • Uses outdated IQ-, OQ- and PQ-based validation now superseded by latest best practice

  • Largely static set-up could mean theoretically quick validation at the expense of long-term malleability 


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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

  • Plug-and-play API integrations with Salesforce, Jira, Zephyr, Xray, Azure DevOps, Asana, TestRail and ComplianceWire, with NetSuite integration on the way

  • Connector Read and Write APIs make integration with other systems possible with extra work

  • No native integrations


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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

  • Unlimited free basic document and training access turns Qualio into a business-wide quality tool

  • Modular, fixed set-up impedes scalability

  • Less intuitive UI may impede wider adoption and long-term scalability

  • Modular pricing may be cost-prohibitive for companies wanting to expand into new system areas

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

  • High marks from customers for responsiveness, level of support, and general satisfaction

  • Presence in Minnesota only - international support capabilities unclear

  • No additional service or content offerings - software only 

  • Limited customer reviews online

Choose Qualio if you:

  • Are a medical device, pharma, biotech or contract organization after a flexible, scalable eQMS

  • Want your eQMS to easily integrate with multiple tools

  • Need configurable event management capability, native document editing or strong design control functionality

  • Need expert quality and compliance guidance as well as pre-built document templates

Choose Grand Avenue if you:

  • Are a medical device company wanting a fixed system for rigid compliance

  • Don't need native eQMS integrations

  • Need dedicated equipment management functionality

  • Want a modular, system-only investment