Qualio or SimplerQMS? eQMS comparison

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

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


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, 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


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


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

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

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


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


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

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	M-Files and Microsoft build means strong integration in these areas, but little elsewhere API makes integration with other systems possible with extra work

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, '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


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