Qualio or SOLABS? 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 multi-product 'QM10' eQMS: QS Essentials plus separate 'APPS'
Founded 1999
50+ customers
Paperless eQMS available in the cloud or on-premise
Supports/simplifies quality and compliance
Designed for medium-sized companies
Life science focus

Features, functionality and usage

Document management

Cloud-based document library with e-signatures, native editing, tagging, templates and review/control workflows
Documents edited and collaborated on within the system

Document control module allows storage, categorization and control of documents
No native editing or collaboration - documents must be downloaded, edited and re-uploaded using other tools like Office. Potential integrity issues if not used correctly

Training management


Train users on eQMS documents and house training records in a digital repository Assessments test understanding Build and cascade Training Plans for proactive team training	Optional add-on module for training users on stored documents; Questionmark integration available Assessments test understanding No ability to set pre-requisite training

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 add-on modules for different event types: CAPA, change control, complaints, deviations, investigations, etc. Fixed process workflows with limited configuration

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 design control functionality Only specific medical device functionality for complaints and non-conforming material (both modules in development)

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	No supplier management functionality. CAPA module could be applied as a workaround to fix supplier issues

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

Dedicated audit management module for routing audit-related actions (planning, prep, response, etc.) internally
Fixed flowchart-based process with limited configuration

Equipment management


Quality event forms can be configured to capture and respond to equipment and asset data	CAPA module could be configured to capture and respond to equipment and asset data

Analytics


Rich analytic dashboards for at-a-glance visibility of document, training, event and supplier management activity Dive into visual eQMS data to spot trends, fix bottlenecks and more	No native analytic functionality - data can be exported into canned Excel spreadsheets run through SharePoint 'Reports Portal' Limited reports available and manual SharePoint integration required

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	Dated UX with some customer reports of unintuitive functionality and difficulty sourcing information Siloed modular set-up and limited analytics could make cross-system traceability more difficult

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- and OQ-based computerized system validation (CSV) pack now superseded by latest best practice More modules = longer implementation time

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	Office integration needed for document creation and updates Questionmark integration for training

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 eQMS quick and easy Unlimited free basic document and training access turns Qualio into a business-wide quality tool	Designed for more established companies already at medium size Less modern UI may impede wider adoption, fixed structure could affect long-term scalability Modular structure could allow expansion into new system areas as required

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	Product and technical support from US and Canada offices No pre-built QMS documentation templates provided, no additional quality and compliance support Positive reviews from customers for fast support and openness to product suggestions

Choose Qualio if you:

Need dedicated design control, analytics and supplier functionality
Want a flexible, scalable system that grows with you and is built for ease of use
Want to integrate your eQMS with multiple tools like CRM and design platforms
Want connected eQMS processes, like event management, run from a single area

Choose SOLABS if you:

Need dedicated audit management and lab investigation modules
Want a more fixed eQMS with set flowchart processes
Don't need system integrations beyond Office and Questionmark
Want a modular building-block system to build up over time