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.
Elevating supplier compliance and qualification standards
Navigating the intricate landscape of regulated industries, companies grapple with confirming that their suppliers adhere to strict compliance and quality standards. It’s not just about on-time deliveries and cost efficiencies — it’s about safety, the integrity of the supply chain and meeting rigorous regulatory mandates. The question is, how can the companies effectively manage and qualify their myriad suppliers to meet these standards without getting entangled in a web of complexity? The answer is utilizing ComplianceWire®, which not only streamlines the process but demonstrates control over your supplier network.
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.
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.
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.
Customize your training
With our easy-to-use- content creation tool, CourseCreate, you can customize ComplianceWire® training and further address your training requirements by adding your own tailored content.
Get even more from your LMS with professional support services
Connect with dedicated life sciences-centric professionals and advisory experts
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.
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.
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.
Trusted by companies worldwide
More than
600 million+
training completed
More than
600+
websites
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.
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.
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.
Natively compliant with 21 CFR Part 11 regulatory requirements
Automated, role-based assignment functionality
Seamless integration with enterprise-quality software ecosystems
Easy dashboard views of organizational risk
Powerful ad hoc reporting and over 250 audit-ready standard reports
Flexible, unlimited security roles
Part 11-compliant electronic signatures
Multiple learning assessment options and on the job training (OJT) support
Thirty-four languages available, for both platform and content
Distribute your own standard operating procedures (SOPs), videos or SCORM and AICC learning content
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.
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