Qualio or SimplerQMS?

A balanced eQMS comparison to help you decide





See why our customers prefer us

The lowdown


  • Holistic, integrated eQMS

  • Founded 2012

  • 500+ customers

  • Cloud-based, paperless, market-tested eQMS

  • Supports/simplifies quality and compliance

  • Designed for SMEs

  • Life science focus


  • Modular eQMS

  • Founded 2017

  • 100+ customers

  • Cloud-based, paperless, market-tested eQMS

  • 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 e-signatures, native editing, tagging and templates

  • Documents edited and collaborated on within the system


  • Cloud-based document library with e-signatures, 'relations' and templates

  • Office integration means documents must be edited in third-party Office software then updated in the system

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, change control, deviations and non-conformances

  • Largely static templates with limited configuration

  • Some customers report overly manual issue tracking and difficulty understanding/applying pre-built system workflows 

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

  • No specialized design control functionality - only management of design control documentation

  • Connects to risk module for logging of device risks alongside design documents

  • No integration with design tools - customer review mentions clunky product management processes requiring manual workarounds

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 supplier database with workflows for onboarding and assessment

  • Link supplier records to products, CAPAs, audit plans and so on 

Audit management

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

  • Intuitive system UX and visible metrics make it easy to pinpoint weaknesses and demonstrate compliance to external auditors

  • Apply system templates to capture audit findings

  • Schedule audits with calendar and 'metadata cards', build audit plans of multiple audits


Equipment management

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

  • Equipment calibration module allows calibration tasks to be assigned and logs to be stored


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

  • Built on M-Files platform; outdated and clunky UX in places

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

  • Some customer reviews of slow load speeds, bugs, some usability quibbles, and difficulty adapting to system 'metadata'

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, 'pre-configured' nature of the system means theoretically quick validation possible (5-6-week promise online) but 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

  • M-Files and Microsoft build means strong integration in these areas, but little elsewhere

  • API makes integration with other systems possible with extra work


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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, 'pre-configured' 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

  • Promises product and technical support from offices in Denmark, USA and the Philippines

  • QMS documentation templates provided, but no additional quality and compliance support

  • Appropriate quality best practice not necessarily followed: certified to ISO 13485 despite not producing any medical devices

Choose Qualio if you:

  • Need built-in and robust design control functionality

  • Want a flexible, scalable, widely adopted and highly intuitive system that grows with you

  • Want your eQMS to integrate with multiple tools and be easily adopted business-wide

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

Choose SimplerQMS if you:

  • Need specific equipment and audit management modules in your eQMS

  • Want a fixed, modular and less mature eQMS

  • Only need Microsoft integrations out-of-the-box

  • Only need document templates