Qualio or Arena?

A balanced eQMS comparison to help you make the right choice

 

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G2 Grid® Report for Quality Management (QMS) software | Fall 2022

See why our customers prefer us

The lowdown

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  • Integrated eQMS

  • Launched 2012

  • 500+ customers

  • Cloud-based

  • Supports/simplifies quality and compliance

  • Designed for SMEs

  • Life science focus

Arena

 

  • PLM and QMS products

  • Launched 2000

  • 1300+ customers

  • Cloud-based

  • Supports/simplifies quality and compliance

  • Designed and priced for larger organizations

  • Medical device hardware/product development focus

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Features, functionality and usage

Document management

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  • Cloud-based document library offering complete lifecycle control

  • Version control and GDocP baked in at all times



  • In-system editing of documents and structured document templates
  • Cloud-based document library offering complete lifecycle control

  • Lack of in-system document editing means documents must be downloaded, edited then re-uploaded, potentially introducing integrity risks

  • Some customer reports of slow document retrieval times and poor search experience

Training management

 

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  • Train users and user groups on system documents quickly and easily. Tight integration with system documents library

  • Compliant e-signatures and full training record traceability, including completion metrics


  • Push training and retraining according to preference. New document versions contain highlighted changes for retraining

  • Push training to system users for completion


  • Compliant e-signatures and training record traceability, but some customers report difficulty generating and finding training metrics in the system

  • Convoluted training around documented deviations. Retraining is forced for any document update, with no indication of the document changes

Quality event management

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  • Fully configurable digital workflows for managing any kind of quality event: complaints, CAPAs, change control, deviations 

  • Designed with logical, closed-loop, end-to-end traceability and ease of use

 


  • Arena Tickets offers issue management functionality, but largely inflexible with limited workflow configurability

  • Customers report messy and complicated event management functionality

Design controls

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  • Dedicated Design Controls functionality added to the eQMS in 2020


  • Provides full control/traceability of design elements to bring a medical device to market

  • Pulls design elements automatically from your other testing systems like Jira, Azure DevOps, Asana, Zephyr, Xray or TestRail

  • PLM and QMS systems are highly product-focused


  • Contains all functionality needed for effective design controls, but PLM system requires extra investment

  • Arena PLM integrates with Onshape, Altium and other CAD/MCAD platforms

Audit management

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  • No dedicated audit functionality, but quality event forms and workflows can be configured to capture and respond to audit data

  • No dedicated audit functionality

Supplier management

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  • Build a configurable database of your supply chain


  • Set bespoke policies for manufacturers, service providers, distributors, consultants and more – then use them to enforce supplier requirements, generate/store key documents and ensure compliance

  • Attach audit histories, connected issues, findings and documents to each supplier

  • No supplier management functionality - product focus is on supplier collaboration

  • Supplier licensing through Arena Exchange and Scribe allow suppliers to collaborate on product design

Ease of use

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  • Designed with natural, intuitive ease of use at the core


  • Clean, minimal UX in a cloud-based system to maximize user engagement and simplify training and onboarding

  • Consistently ranked the easiest eQMS software to set up and use


  • Complex, inflexible system with layers of functionality reflected in lower customer usage satisfaction score

  • Some areas of the system noted as messy, complicated and unintuitive by users - may damage internal adoption

Implementation & validation

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  • Statistically the fastest eQMS to implement, validate and begin using


  • Follows the latest FDA and GAMP computerized system assurance (CSA) guidelines for a rapid, least burdensome validation approach for customers

  • Validation document pack provided with all objective functional evidence of system suitability. Customers need only perform extra software testing if they feel it’s risk-appropriate

  • Industry-leading implementation support with minimal resource needs


  • Arena Validate package provides all objective functional evidence of system compliance, leaving customers to focus on validation of their unique intended use

  • Still follows outdated OQ-, IQ- and PQ-based CSV pathway, adding unnecessary time and work to the validation experience

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


  • Strong integration focus: connects to a range of ERP, design, component and CRM platforms 


  • Other custom API integrations available at extra cost

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 QMS quick and easy

  • Tight focus on life science start-ups and scale-ups means scalability and growth a central system component


  • Designed and priced for larger enterprise companies - already a 'large' deep product which may overwhelm SMEs

  • Complicated, inflexible structure impedes real scalability

Customer focus

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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/RA expert support and pre-built standard-specific system templates to accelerate compliance

  • Partner network of consultants and experts for further help 


  • Product and support designed for life science companies

  • G2 Net Promoter Score: 62


  • Offers product and technical support. Arena Classes offer 10-15-hour functionality classes which reflect the complexity of the product

  • Software only: no expert QA/RA support. Generic ECO, BOM, AML and item master templates downloadable from the website

  • No specific industry focus for product or support; used by medical device, electronic, aerospace, transport and clean tech customers

  • G2 Net Promoter Score: 34

 

Choose Qualio if you:


  • Are a life science company

  • Are a growing SME

  • Want a targeted, life science-focused quality system with all required functionality

  • Want an agile, configurable, easy-to-use system that connects to your other business-critical tools

Choose Arena if you:


  • Aren't a life science company 

  • Are a large enterprise business with a large budget

  • Want a joint QMS-PLM platform with a strong product management focus

  • Want a fixed, complex system with design or ERP ecosystem connection