Discover how our validated, FDA CFR Part 11 compliance training management system helps you comply with evolving FDA regulations
Medical device and pharmaceutical manufacturers trying to keep up with the ever-changing regulations have a tough job. Medical technology advances quickly, and with it, a regulatory compliance system designed to keep patients safe. 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®. ComplianceWire️® is an industry-leading training learning management system (LMS) for compliance and qualification management created for life sciences organizations. It is natively compliant with FDA 21 CFR Part 11 and EU Annex 11 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. ComplianceWire® helps to promote public health by helping to train qualified individuals to increase the safety and effectiveness of medicines and medical devices.
Meet FDA requirements for GxP training, 21 CFR Part 11, EU Annex 11
ComplianceWire® delivers proven learning solutions from trusted experts to FDA-regulated companies.
Globally recognized LMS
Validated, audit-ready learning management system with over half a billion completions that supports over 3.6 million users in over 130 countries and 34 languages.
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 110 courses developed jointly by the U.S. Food and Drug Administration (FDA) and UL Solutions.
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.
Learning consultants and custom content services are available to help you design and deliver tailored, company-specific knowledge assets using the most current learning methods for maximum retention.
Expert professional services to help you achieve success through efficient implementations, integrations, data migrations, validation and change management.
Easy integration with enterprise systems (Identity Management, HR, Document, and Quality Management Systems through APIs or custom interfaces), performed by proven and tested professionals with over 100 projects annually.
Increase product safety and record work force qualification with powerful role-based training automation
Key features help our clients make safer medical device and pharmaceutical products quickly and efficiently, with assurance of personnel compliance:
- Extensive, comprehensive audit trails
- Flexible security roles
- Fully compliant electronic signatures
- Multiple learning assessment options
- Multilingual training support in 34 languages
- Flexible on-the-job training (OJT) workflows
- Role-based training assignments
- Real-time reports and dashboards
- Secure integrations with essential enterprise systems
- Robust version control and training assignment logic
- Wide-ranging content options
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 tool 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 ensure 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.