Qualio or MasterControl?

A balanced eQMS comparison to help you make the right choice

See why our customers prefer us

The lowdown

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

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

Features, functionality and usage

Document management


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


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


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


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


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


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

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


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


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

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