Qualio or MediaLab?

A balanced eQMS comparison to help you decide

 

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Qualio vs. MediaLab eQMS comparison

 

See why our customers prefer us

The lowdown

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  • Holistic, integrated eQMS

  • Founded 2012

  • 500+ customers

  • Cloud-based, paperless eQMS

  • Supports/simplifies quality and compliance

  • Designed for SMEs

  • Life science focus

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  • Modular system with primary emphasis on documentation/competency

  • Founded 1995

  • 1500+ customers

  • Paperless cloud-based quality platform

  • Supports/simplifies quality and compliance

  • Size-agnostic

  • Hospital, healthcare and lab focus

Features, functionality and usage

Document management

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  • Cloud-based document library with e-signatures, native editing, tagging, templates and review/control workflows

  • Documents edited and collaborated on within the system


  • White-glove onboarding service for easy migration of your old document stack


 

  • Document control module allows storage, categorization and control of documents with compliant e-signatures

  • No native editing or collaboration - documents must be downloaded, edited and re-uploaded

  • Some customers report difficult migration of legacy documents, and low-resolution documents once in the platform

Training management

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

  • Assessments test understanding and prove operational compliance



  • Build and cascade Training Plans for proactive team training


  • 'Compass' module offers competency assessments, quizzes and configurable checklists

  • Additional continuing education library available in 'Competency Assessment Hub' for major disciplines like histology and phlebotomy: ASCLS PACE credits awarded

  • More an LMS than training management system

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


  • 'IQE' module can be used to configure workflows for management of CAPAs, investigations and non-conformances

  • Configurable forms to capture the information you need

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 design control functionality




  • Not designed for medical devices

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


  • No supplier management functionality. IQE module could be applied as a manual workaround to fix supplier issues with event workflows

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


  • InspectionProof module allows organization of documents, tasks and checklist responses for audit and inspection readiness

  • Limited analytics for shoring up compliance

 

Analytics

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  • 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


  • Some basic analytic functionality - non-configurable charts for system activity

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


  • Dated UX with some customer reports of cluttered, confusing functionality and difficulty navigating and assigning user permissions

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


  • Validation methodology unknown



  • Complex, multi-solution platform could mean longer implementation time

Ecosystem

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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


  • Office integration (needed for document creation and updates)



  • No other integrations out-of-the-box

Scalability

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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 eQMS quick and easy

  • Unlimited free basic document and training access turns Qualio into a business-wide quality tool


  • Complicated UI may impede wider adoption


  • Modular structure could allow expansion into new system areas as required, but with additional user costs

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


  • Product and technical support from US office



  • No pre-built QMS documentation templates provided, no additional quality and compliance support


  • Unlimited basic support, premium support requires an additional fee

Choose Qualio if you:


  • Run a medical device, pharmaceutical, biotech, laboratory or contract operation

  • Want a flexible eQMS to tailor to your exact business needs, with pre-built quality document templates available


  • Want to integrate your eQMS with multiple tools like CRM and design platforms

  • Want ease of use, high-touch support and high user engagement at the center of your eQMS adoption

Choose MediaLab if you:


  • Run a hospital or healthcare operation


  • Want an eQMS geared towards this vertical, including an inspection readiness module and a learning management system with pre-built courses and professional credits

  • Don't need system integrations beyond Office


  • Don't need supplier, design control, in-app document editing or deep analytic functionality