Qualio or TrackWise?

A balanced eQMS comparison to help you make the right choice



G2 Momentum Grid® Report for Quality Management (QMS) software | Fall 2022

See why our customers prefer us

The lowdown


  • Lone flagship product

  • Launched 2012

  • 500+ customers

  • Cloud-based, multi-tenancy, browser-based SaaS

  • Supports/simplifies quality and compliance

  • Designed for SMEs

  • Life science focus



  • Part of Sparta Systems' product suite, acquired by Honeywell in 2021

  • Launched 2018

  • 700+ customers

  • On-premise or cloud (TrackWise Digital)

  • Supports/simplifies quality and compliance

  • Designed and priced for enterprise organizations

  • No industry focus


Features, functionality and usage

Document management

favicon-3 TrackWise


  • Cloud-based document library offering complete lifecycle control

  • Version control and GDocP baked in at all times

  • In-system editing of documents and structured document templates
  • Cloud-based document management system available in TrackWise Digital, built on the Salesforce platform

  • In-browser editing using Office365 integration

  • Some customer reports of slow document find/load times and difficulty tracking the lifecycle 

Training management


favicon-3 TrackWise


  • Train users and user groups on system documents quickly and easily, including records of external training

  • Compliant e-signatures and full training record traceability

  • Users acknowledge document training and exterior courses within the system

  • Compliant e-signatures and full training record traceability

Quality event management

favicon-3 TrackWise


  • Fully configurable digital workflows for managing any kind of quality event: complaints, CAPAs, change control, deviations 

  • System report generation allows analysis and data-driven decision-making

  • Designed with logical, closed-loop, end-to-end traceability


  • Quality and complaint management areas allow construction of workflows for resolving quality events

  • AI support available through QualityWise.ai add-on

  • Some customer reports of overly complex and difficult-to-track records as events are raised and remediated

  • High levels of workflow customization can cause excessive validation burden and difficulty as the system is upversioned

Design controls

favicon-3 TrackWise


  • Dedicated Design Controls functionality added in 2020

  • Provides full control/traceability of design elements to bring a medical device to market

  • Pulls design elements automatically from your other testing systems like Jira, Azure DevOps, Asana, Zephyr, Xray or TestRail

  • No specific Design Controls area, but risk management functionality could offer some ISO 14971 and FMEA support

  • No API integration with device design tools

Supplier management

favicon-3 TrackWise


  • Build a configurable database of your supply chain

  • Set bespoke policies for manufacturers, service providers, distributors, consultants and more – then use them to enforce supplier requirements, generate/store key documents and ensure compliance

  • Attach audit histories, connected issues, findings and documents to each supplier

  • Build a configurable supplier database including scoring, audit history and related incidents

  • Collaborate with suppliers via the TrackWise Digital supplier portal

Ease of use

favicon-3 TrackWise


  • Designed with natural, intuitive ease of use at the core

  • Clean, minimal UX in a cloud-based system to maximize user engagement and simplify training and onboarding

  • Consistently ranked the easiest eQMS software to set up and use

  • Complex system with layers of functionality reflected in lower customer satisfaction score

  • Cloud option highly recommended over on-premise

  • Some areas of the system noted as more clunky and less intuitive than others

Implementation & validation

favicon-3 TrackWise


  • Statistically the fastest eQMS to implement, validate and begin using

  • Follows the latest FDA and GAMP computerized system assurance (CSA) guidelines for a rapid, least burdensome validation approach for customers

  • Validation document pack provided with all objective functional evidence of system suitability. Customers need only perform extra software testing if they feel it’s risk-appropriate

  • Industry-leading implementation support with minimal resource needs

  • Complex, heavy system means longer, more resource-intensive implementations 

  • High levels of customization demand extra validation and risk assurance work

  • Validation document pack provided with all objective functional evidence of system suitability. Layers of customization mean more validation work for the customer


favicon-3 TrackWise


  • 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

  • Built on Salesforce platform, providing API integration with enterprise tools like ERPs and manufacturing systems

  • Extra integration work may mean extra cost


favicon-3 TrackWise


  • 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

  • Tight focus on life science start-ups and scale-ups means scalability and growth a central system component

  • Designed for larger enterprise companies - already a 'large' deep product which may overwhelm SMEs

  • On-premise version of TrackWise much more difficult to scale than TrackWise Digital

Customer focus

favicon-3 TrackWise


  • 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/RA expert support and pre-built standard-specific system templates to accelerate compliance

  • Partner network of consultants and experts for further help 

  • Product and support designed for life science companies

  • G2 Net Promoter Score: 62

  • Offers customer success, product and technical support. Sparta Academy houses a large product curriculum to reflect the complexity of the product

  • Software and templates only: no expert QA/RA support

  • Partner network of consultants and experts for further help 

  • No specific industry focus for product or support

  • G2 Net Promoter Score: 37


Choose Qualio if you:

  • Are a life science company

  • Are a growing SME

  • Want a targeted, life science-focused quality system with all required functionality

  • Want a fast implementation backed by close industry-specific support

Choose TrackWise if you:

  • Aren't a life science company 

  • Are a large enterprise business with a large budget

  • Want an on-premise quality system or a Salesforce-based platform

  • Need a complex, bells-and-whistles quality system with a little more work and set-up required