Qualio or Arena?

A balanced eQMS comparison to help you make the right choice

linkedin_G2fall22-qualio-vs-arena

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

The lowdown

Document management


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


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

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


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


Quality event forms and workflows can be configured to capture and respond to audit data	No dedicated audit functionality

Supplier management


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


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

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


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


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

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

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