Qualio or MasterControl?

A balanced eQMS comparison to help you make the right choice

 

HubSpot Video

 

See why our customers prefer us

The lowdown

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  • Flexible, configurable software to match, evolve and scale with you

  • Founded 2012

  • 500+ customers

  • Cloud-based, paperless, market-tested eQMS

  • Supports/simplifies quality and compliance

  • Designed for SMEs

  • Life science focus

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  • Fixed, module-based software with limited configuration

  • Founded 2000

  • 1000+ customers, including the FDA

  • Cloud-based, paperless, market-tested eQMS

  • Supports/simplifies quality and compliance

  • Designed and priced for large enterprise businesses

  • No industry focus; broad focus on quality and manufacturing

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G2 Momentum Grid® report for quality management (QMS) software | Fall 2022

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Features, functionality and usage

Document management

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  • Managed with native editing of configurable document templates within a cloud-based library


  • Version control and GDocP baked in as standard


  • Designed for ease of use and rapid searchability/retrieval
  • Cloud-based document library. Lack of native editability means documents must be edited with download and re-upload or integration with editing tools

  • Potential version control and integrity weaknesses if not used correctly

  • Customers report long load times and difficulty searching for documents

Training management

 

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

  • FDA- and EU-compliant e-signatures


  • Push training to users and store completed training records


  • FDA- and EU-compliant e-signatures

 

Quality event management

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


  • Configurable workflows for all core quality management activity

  • Largely fixed with limited ability to evolve processes - reports from customers of manual spreadsheet work to support configurations

Design controls

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  • Centralizes and manages all design traceability and elements for easy collation of Design History File

  • Ecosystem focus means the system pulls design elements automatically from your other testing systems like Jira, Azure DevOps, Asana, Zephyr, Xray or TestRail with plug-and-play API integrations


  • Manage design documents and artifacts in a central location


  • Custom API integrations with your device design tools could be set up with some additional work/cost

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 and export Approved Supplier Lists (ASLs) as required


  • Supplier management module offers core functionality for managing your supply chain


  • Separate system areas for managing supplier lists, documents, scoring and SCARs

 

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


  • Designed with a Microsoft-style UI, but strong consistent feedback from users about difficulty of use and unintuitive experience

  • Complex, clunky, complicated and multi-layered system requires a 2-week starter training course and module-specific subject matter experts

  • 'MasterControl Hell' and slow system speed reported by customers

 

Implementation & validation

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  • Follows 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 Excellence Tool (VxT) promises validation in 'hours', but this doesn't take customer validation demands into account


  • Complex functionality and sheer size of the system demands more risk-based validation considerations from the customer


  • Old CSV documents like IQs, OQs and PQs still used despite latest best practice

  • Implementation time frames can be 150+ days depending on package complexity

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


  • Integrations with 'hundreds' of systems, including SAP, Salesforce and Oracle


  • Long and complex process required to set up integrations, with 14-week lead times

  • Custom API integrations available for extra work and 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

  • Priced for smaller companies to make system scaling natural and painless as your company grows


  • Rigid and inflexible set-up impedes scalability


  • Poor user experience may harm internal adoption and usage scalability

  • Extremely cost-prohibitive for smaller companies to scale; some customers report wanting to scale up their eQMS, but not being able to secure budget for extra modules

 

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

  • G2 Net Promoter Score: 62


  • Offers maintenance support, self-service web portal and custom/premium support options for an extra fee. 3 layers of product support offerings with different costs and add-ons

  • No QA expert support or system content. GMP JumpStart provides some out-of-the-box configuration best practice to accelerate GxP compliance.

  • Some customer reports of long back-and-forth fixes to address system issues

  • G2 Net Promoter Score: -9

 

Choose Qualio if you:


  • Are a small- to medium-sized life science business

  • Want a flexible, scalable eQMS to grow with you to market and beyond

  • Want a focused, easy-to-use eQMS with everything you need for robust quality and compliance

  • Want to work with a company with fewer, happier customers

Choose MasterControl if you:


  • Are an enterprise organization or a non-life science company

  • Want a fixed, modular system suitable for large operations

  • Want a complex eQMS with layers of functionality but higher user and price demands

  • Want to work with a company with more customers and a more established market presence