Qualio or Dot Compliance?

A balanced eQMS comparison to help you decide






See why our customers prefer us

The lowdown


  • Singular, integrated eQMS platform

  • Founded 2012

  • 500+ customers

  • Cloud-based

  • Supports/simplifies quality and compliance

  • Designed for SMEs

  • Life science focus


  • 11-module eQMS platform spread across 3 products

  • Founded 2015

  • 200+ customers

  • Cloud-based

  • Supports/simplifies quality and compliance

  • No customer size focus

  • Life science focus

Features, functionality and usage

Document management

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  • Cloud-based document library with all modern functionality such as e-signatures and viewing permissions

  • In-system editing with version control and GDocP baked in as standard
  • Cloud-based document library with all modern functionality such as e-signatures and viewing permissions

  • No in-system editing; documents must be checked out, updated and checked in through Word integration, with potential integrity weaknesses if used incorrectly

  • System displays superseded SOPs and overwrites custom numbering - potential version control and traceability weaknesses without full awareness

  • Some customer reports of long search and load times, and clunky review processes

Training management


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

  • Push training, prompts and reminders to users with workflows and track organizational and departmental training status

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

  • Push training, prompts and reminders to users with workflows and track organizational and departmental training status

  • Open training not readily visible from system Dashboard; must be searched for

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. 

  • Separate siloed modules for deviations/NCRs, CAPAs, change control and other events

  • Some customer reports of complex, difficult-to-understand workflow building

Design controls

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  • Centralizes and manages all medical device design elements for easy collation of Design History File

  • Pulls design elements automatically from your other testing systems like Jira, Azure DevOps, Asana, Zephyr, Xray or TestRail with plug-and-play API integrations

  • No design control functionality

  • Risk management module could provide some device risk control, but not the full range of design controls

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, nominate approvers and export Approved Supplier Lists (ASLs) as required

  • Add and manage suppliers in the supplier management module

  • Track quality events linked to suppliers

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 use by life science quality professionals

  • Modern interface built on Salesforce platform

  • Customer reports of steep learning curve and usability quirks - considerable training required during system set-up for full adoption

Implementation & validation

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  • Modern validation approach: guided by the latest FDA and GAMP computerized system assurance (CSA) guidelines for a rapid, least burdensome experience 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

  • Ranked the easiest eQMS to set up by real G2 reviewers

  • System positioned as 'fully validated' - potentially misleading labeling which ignores the latest industry expectations of validation activity on the customer side

  • Taking all 11 modules could require a large amount of customer validation work

  • Reliance on Microsoft Word for document editing adds an extra layer of validation considerations - feature-dense, auto-updated third-party tool governs document activity

  • Some customer reports of incomplete training and implementation, damaging adoption and sentiment


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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

  • Built on Salesforce platform with open API

  • Website mentions 'AI', 'IoT' and 'Big Data' integrations, but unclear what this means in practice


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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

  • Established, market-tested product with all functionality available now

  • Tiered system structure for companies to scale through: QMS Xpress, Compliance Xpand, Enterprise Xact

  • Tiered pricing could add a ceiling to scalability, depending on your budget

  • Siloed modular structure and usability learning curve could make scaling a holistic quality approach more difficult

Customer support

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  • Commits to a long-term partnership with customers. Onboarding/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

  • Offers customer success, implementation and support services

  • No QA support or QMS content provided

  • Some customers dissatisfied with set-up and training for long-term success

Choose Qualio if you:

  • Want an integrated, holistic life science eQMS to scale with you

  • Need medical device design control functionality 

  • Want an established, market-trusted product with over ten years of customer usage

  • Want the easiest eQMS to set up, use and extract value from

Choose Dot Compliance if you:

  • Want a modular eQMS with a tiered scaling pathway

  • Don't need any medical device design control functionality

  • Want a dedicated regulatory submission module

  • Want a system built on the Salesforce platform