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

The lowdown

Document management

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


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

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

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

Audit management


Quality event forms and workflows 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


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


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

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


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


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


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

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

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