Qualio or ZenQMS?

A balanced eQMS comparison to help you make the right choice

 

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

See why our customers prefer us

The lowdown

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  • Founded 2012

  • 500+ customers

  • Cloud-based, multitenancy, browser-based SaaS

  • Supports/simplifies quality and compliance

  • Designed for SMEs

  • Life science focus

ZenQMS



  • Founded 2009

  • 200+ customers

  • Cloud-based, multitenancy, browser-based SaaS

  • Supports/simplifies quality and compliance

  • No company size focus

  • Life science focus

G2 Qualio ZenQMS comparison

Features, functionality and usage

Document management

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  • Complete cloud-based control of document lifecycle

  • Part 11 and EU Annex 11 e-signatures

  • Version control and GDocP baked in at all times

  • Fast and easy collaboration and review with configurable workflows and system reminders

  • Higher customer satisfaction for collaboration and reporting functionality

 


  • Cloud-based library with edit, export and folder options

  • Part 11 and EU Annex 11 e-signatures

  • Limited flexibility for collaboration: maximum of 3 authors for document drafting

  • Customer reports of 'slow' and 'illogical' update and revision processes, with clunky exporting and no notifications for key document activities

Training management

 

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  • Train users on system documents with e-signatures, reminders and configurable quizzes

  • At-a-glance visibility and reporting of training metrics, like outstanding and completed training

  • Assign role-based training to users on the fly with reminders and full system recording

  • Clunky reporting of training metrics, difficult to compare departmental training statuses. Some customer reports of general inflexibility

Quality event management

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

  • Single system area for managing all quality processes, including change control

  • API integration to pull and resolve CRM customer issues straight from Salesforce

 


  • Highly configurable workflows for managing any kind of quality event: complaints, CAPAs, deviations 

  • Change control siloed in a separate module 


  • Some customer reports of only basic, limited configurability not meeting process requirements, with some non-digital workarounds required

  • No API integration to pull quality events and issues from other systems

 

Design controls

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  • Dedicated Design Controls functionality added 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

 


  • None

Audit management

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

  • Dedicated module for scheduling audits, including an in-system audit calendar and finding logs

  • Some customer reports of 'rocket science' functionality and long, complex admin

Supplier management

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  • Build a configurable database of your supply chain in a dedicated system area

  • 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

  • No dedicated system area; functionality lumped into Audits module


  • Build and manage supplier qualification assessments

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


  • Iterative, customer feedback-based continuous improvement

  • Designed with simplicity and basic look and feel - high marks from customers for ease of use

  • Cloud-based system for remote access from anywhere


  • Fast, easy onboarding, but some system areas less intuitive and easy to use than others

  • Less established product with fewer customers = less feedback and customer-centric development

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

  • Industry-leading implementation time frame: 60-day target


  • GAMP Category 4

 



  • Still follows outdated IQ-, OQ- and PQ-based validation process which adds unnecessary complexity and work


  • 90-day implementation target


  • GAMP Category 4

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


  • Ecosystem not built into product roadmap: no API integration capability

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 makes scalability and growth a central system component


  • Flat fee allows unlimited users to be added at no extra cost


  • Siloed modular structure and reported usability difficulties for some system areas may harm engagement and long-term scalability potential

  • Broad company size focus makes scalability a less integral part of the product

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 expert support and pre-built standard-specific system templates to make you an expert and accelerate compliance


  • Product and technical support priced according to your business size and complexity, with support in US, Brazil and Romania


  • Software only: no regulatory content, template documentation or expert QA/RA support

Choose Qualio if you:


  • Are a medical device company that needs dedicated design control functionality

  • Need a cloud-powered life science eQMS with high configurability to scale with you

  • Use other software tools and want to connect them to your quality system

  • Want a widely-used and highly reputable industry tool supported by templated content and QA expertise

Choose ZenQMS if you:


  • Need separate modules for audit and change control management 


  • Don’t want high levels of configuration/scalability


  • Don't need to connect your QMS to other business tools such as your CRM or LMS

  • Want a popular niche QMS tool without any content or QA support