Learning management technology and expertise for highly regulated industries
ComplianceWire® is the best-in-class web-based platform designed specifically for highly regulated industries. It is designed to effectively and efficiently automate the creation, delivery, and reporting of your role-based training, qualification and compliance programs. ComplianceWire was built from the ground up to be fully compliant with 21 CFR Part 11 and EU Annex 11 validation requirements. Known as the ‘Gold Standard’ Learning Management System (LMS) for the Life Science industry, this time-tested technology is used extensively by U.S. and global pharmaceutical, medical device and biologics companies as well as global regulatory authorities in the US, China and India.
A comprehensive approach to regulatory compliance
Our comprehensive compliance training solution integrates three critical components:
- Globally-recognized LMS technology that enables the creation and automation of compliant, effective and efficient training programs
- Knowledge assets that include:
- Library of more than 1,000 eLearning training modules
- Catalogs containing over 500 Life Science specific courses
- 110 of these courses developed jointly by the FDA and UL
- Prompt, personalized support delivered by expert training professionals
The learning management technology chosen by the FDA
For over 20 years, ComplianceWire®, as well as UL’s life science e-learning courses, have been the trusted learning solution used by the U.S. Food and Drug Administration (FDA) to train more than 36,000 global, federal, state and local investigators. The agency chose the ComplianceWire® platform as their training solution to ensure the proficiency of their investigators under a unique cooperative research and development agreement (CRADA). This solution integrates the ComplianceWire® web-based platform with curricula UL co-developed with the FDA. The same technology platform and coursework used by the FDA in its virtual university are available exclusively to UL’s customers.
Compliant with 21 CFR Part 11 and EU Annex 11 validation requirements
As part of the implementation, customers receive validation summary reports, Part 11 white papers, audit with our quality team, and validation test scripts. Employees can be automatically sorted into training groups based on criteria such as job function. The functionality governs 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 standard operating procedures.
Backed by life sciences online training content
ComplianceWire® is built to support AICC and SCORM learning content. Our professional development education training courses carefully target the diverse needs of learners, regardless of industry, language, culture or education:
- FDA-authored and/or reviewed courses identical to those used by the FDA to train its inspectors and investigators
- More than 600 life science industry courses off -the-shelf, including 100+ co-developed with the FDA
- Standardized courses on issues regulated by federal agencies including the OIG, SEC, EPA, OSHA and HHS
- Curricula focused on critical workplace subjects ranging from employee confidentiality to sexual harassment, site security, health and safety, and data integrity
- The ability to customize or create new training content, working with UL’s design team or through our course self-authoring tool, Create
Over 630+ organizations and 3+ million active individual learners trust ComplianceWire for their compliance and learning needs.