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Learning and Qualification Management System

Navigate life science regulations, automate training and implement risk management to support development of safer and more effective medical products.

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Discover how our validated, FDA CFR Part 11 compliance training management system helps you comply with evolving FDA Regulations

Keep your workforce up to date

Medical device and pharmaceutical manufacturers trying to keep up with ever-changing regulations have a tough job. Medical technology advances quickly, and with it the need for compliance systems to support patient safety. To help you and your workforce stay up to date with the latest U.S. Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) training, HIPAAA training, ISO 14971 training and more, we created ComplianceWire®.

Automated life science learning management

ComplianceWire Learning and Qualification Management System, part of ULTRUS™ software from UL Solutions, is an award-winning, industry-leading training learning management system (LMS) for compliance and qualification management created for life sciences organizations. ComplianceWire is natively compliant with FDA 21 CFR 11 and EU Annex 11 electronic records validation requirements. This proven technology Is used globally by pharmaceutical, medical device and biologics companies as well as global regulatory authorities in the U.S., China, Brazil and India. Using ComplianceWire, life sciences companies can help support the safety and effectiveness of their products through robust, automated training capabilities for employees.

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Meet FDA Requirements for GxP training, 21 CFR Part 11, EU Annex 11

ComplianceWire® delivers powerful learning capabilities developed by life sciences experts for FDA-regulated companies.


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Globally recognized LMS

Validated, audit-ready learning management system with over 700 million completions that support over 1.5 million users in over 130 countries and 34 languages.

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e-learning library

Library of high-quality, engaging knowledge and content assets, including more than 1,000 e-learning training modules, over 400 life science-specific courses and 52 courses developed jointly by the U.S. FDA and UL Solutions.

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Customize your training

With our easy-to-use- content creation tool, UL Create™, you can customize ComplianceWire® training and further address your training requirements by adding your own tailored content.

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Get even more from your LMS with professional support services

Connect with dedicated life sciences-centric professionals and advisory experts


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Tailored content

Learning consultants and custom content services are available to help you deliver tailored, company-specific knowledge assets using the most current learning methods for maximum retention.

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Support, when and where you need it

Expert professional services to help you achieve success through efficient implementations, integrations, data migrations, validation and change management.

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Easy integration

Integration with enterprise systems (identify Management, HR, Document, and Quality Management Systems through APIs or customer interfaces), performed by proven and tested professionals with over 100 projects annually.

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Trusted by companies worldwide

More than

600 million+

training completed

More than



More than

3.6 million+

learners worldwide

Trust the learning management technology used by the FDA

Since 1999, ComplianceWire® and UL Solutions life science e-learning courses have been the FDA’s trusted learning tools to train more than 70,000 global, federal, state and local investigators. The agency chose the ComplianceWire® platform as part of its Office of Regulatory Affairs (ORA) training infrastructure, to build up the proficiency of its investigators under a unique Cooperative Research and Development Agreement (CRADA). This service integrates the ComplianceWire® web-based platform with curricula UL Solutions co-developed with the FDA.

This same technology platform and coursework used by the FDA to train its inspectors and investigators in its virtual university are available to UL Solutions customers.

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Align with 21 CFR Part 11 and EU Annex 11 validation requirements

As part of each implementation, customers receive validation summary reports, Part 11 white papers, an audit with our quality team and validation test scripts. Employees can be automatically sorted into training groups based on criteria such as job function, effectively governing the role-based training process. Automated version control lowers the risk of human error from manually performing multiple version reconciliations and updating a library of constantly changing SOPs.

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Increase product safety and record work force qualification with powerful role-based training automation

Key features help our customers manufacture safer medical device and pharmaceutical products quickly and efficiently, with tools to support personal compliance.


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Natively compliant with 21 CFR Part 11 regulatory requirements
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Automated, role-based assignment functionality
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Seamless integration with enterprise-quality software ecosystems
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Easy dashboard views of organizational risk


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Powerful ad hoc reporting and over 250 audit-ready standard reports
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Flexible, unlimited security roles
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Part 11-compliant electronic signatures
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Multiple learning assessment options and on the job training (OJT) support


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Thirty-four languages available, for both platform and content
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Distribute your own standard operating procedures (SOPs), videos or SCORM and AICC learning content




Ready to boost your life sciences training and e-learning capabilities?

Schedule a demonstration to learn how ComplianceWire can help you navigate complex regulatory requirements.

ComplianceWire® and ULTRUS™ software

ComplianceWire® is now part of ULTRUS software, which brings together flagship digital offerings from UL Solutions to help customers manage their regulatory, supply chain and sustainability challenges.

Learn about ULTRUS

Ready to boost your life sciences training and e-learning capabilities?

Schedule a demonstration to learn how ComplianceWire can help you navigate complex regulatory requirements.

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