Qualio or Enzyme? eQMS comparison

The lowdown

Holistic, integrated eQMS
Founded 2012
500+ customers
Cloud-based, paperless eQMS
Supports/simplifies quality and compliance
Designed for SMEs
Life science focus

Modular eQMS platform with 'core', 'premarket' and 'postmarket' modules
Founded 2017
200+ customers
Paperless cloud-based quality platform
Supports/simplifies quality and compliance
Designed for SMEs
Life science focus with emphasis on digital health/SaMD

Features, functionality and usage

Document management


Cloud-based document library with e-signatures, native editing, tagging, templates and review/control workflows Documents edited and collaborated on within the system White-glove onboarding service for easy migration of your old document stack	Document control module allows storage, categorization and control of documents with compliant e-signatures No native editing or collaboration - Google Doc changes synced into system, or Microsoft documents uploaded

Training management


Train users on eQMS documents and house training records in a digital repository Assessments test understanding and prove operational compliance Build and cascade Training Plans for proactive team training	'Curriculum' system pushes training as document and event changes occur Training matrix allows at-a-glance visibility of training statuses Quizzes test understanding

Quality event management


Fully configurable workflows in a single area for managing any kind of quality event: complaints, CAPAs, change control, deviations, etc. Editable form templates allow bespoke information capture and response within a scalable, malleable eQMS	Only change control module classed as 'core': complaint, CAPA and nonconformance modules locked as 'postmarket' modules at extra cost CAPA forms follow 4-stage process and complaints follow 2-stage approval process with limited configuration

Design controls


Dedicated design control area centralizes and manages all medical device design elements for easy collation of Design History File: ISO 14971 and FMEA risk management, user requirements, open device issues, etc. Pulls design elements automatically from your other testing systems like Jira, Azure DevOps, Asana, Zephyr, Xray or TestRail with plug-and-play API integrations	Design control module centralizes design activity and allows DHF export Integrates with external design systems like Jira, GitHub, CircleCI, Google Drive and Slack Customer reviews mention low levels of configuration compared to other modules

Supplier management


Build a configurable database of your supply chain in a dedicated supplier management area Set bespoke risk policies for manufacturers, service providers, distributors, consultants and more – then use them to enforce supplier requirements and ensure compliance Attach key documents, manage audit details and export Approved Supplier Lists (ASLs) as required	Supplier management module allows construction of a supplier database categorized by risk, product, rating and type Export ASLs as needed Customers report lack of automated reminders for supplier management activities

Audit management

Quality event forms and workflows can be configured to capture and respond to audit data
Intuitive system UX and visible metrics make it easy to pinpoint weaknesses and demonstrate compliance to external auditors

Audit module allows checklists, results and schedules to be stored in a single area
Limited analytics for shoring up compliance

Analytics


Rich analytic dashboards for at-a-glance visibility of document, training, event and supplier management activity Dive into visual eQMS data to spot trends, fix bottlenecks and more	No real analytic functionality or data interrogation

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	Clean and tidy UX with high marks from customers for ease of use Modular set-up and lack of analytics could prevent easy visibility of the broader quality picture

Implementation & validation


Industry supplier guided by 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 methodology unknown; promises 'out-of-the-box' compliance which suggests inflexible GAMP 5 Category 3 system Modular, sectioned set-up would mean extra validation tasks as new modules are added

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 ecosystem: Office 365, Bitbucket, CircleCI, Jira, Cornerstone, GitHub, GitLab, Okta, Zephyr, Google, Jenkins, Salesforce, Slack, Travis CI, Xray and Zendesk offerings

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 eQMS quick and easy Unlimited free basic document and training access turns Qualio into a business-wide quality tool	Tiered 'core', 'premarket' and 'postmarket' pricing structure locks modules into stages, defining how you scale and grow for you Modular structure could allow expansion into new system areas as required, but with additional user costs

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	Support Center with knowledge base and in-app chat support; positive reviews from customers Library of 80+ pre-built QMS documentation templates available 'Community courses' provide life science product development insights for customers; consultancy services also available for an extra fee

Choose Qualio if you:

Want an eQMS consistently ranked the easiest to use and fastest to set up
Want a fully flexible eQMS to tailor to your exact business needs as you scale
Want a single, integrated eQMS that grows with you
Want quality analytics and in-app document editing functionality

Choose Enzyme if you:

Need integrations with Office 365, Google, Slack, or some core CI tools
Want a less flexible system, with structured workflows to guide you
Want a modular system that lets you buy new elements as you expand
Want dedicated audit and risk management modules