Qualio or Grand Avenue? eQMS comparison

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

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


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


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


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


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


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


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


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


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

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	Connector Read and Write APIs make integration with other systems possible with extra work No native integrations

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 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


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