UL’s Part 11 compliant and validated learning management system (LMS) for regulated industries
UL's ComplianceWire️ is the industry-leading compliance training Learning Management System (LMS) specializing in life sciences organizations and is compliant with 21 CFR Part 11 and EU Annex 11 validation requirements. Known as the Gold Standard LMS for the Life Sciences 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 U.S., China, Brazil and India.
A comprehensive approach to regulatory compliance
ComplianceWire integrates these 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 e-learning training modules
- Catalogs containing over 400 life science specific courses, including 110 courses developed jointly by the U.S. Food and Drug Administration (FDA) and UL
- Prompt, personalized support delivered by expert training professionals
- Engaging learning design that delivers quality while reducing training costs
Help ensure compliance with the U.S. FDA and other regulatory bodies worldwide to bring medical device and pharmaceutical products to market safely
Benefits of our comprehensive regulatory compliance training solution:
Assignment-based training functionality—Enables training managers to define role-based qualification groups, with automated group membership and assignment rules, for corresponding requirements curricula.
Automatic audit trails on critical assignment activities — System administrators can access the Event Log to view more than 250 system-provided events, such as “adding an assignment” and “removing a security role from a user.”
Flexible security roles — Administrators can strictly “deﬁne” speciﬁc security access based on the unique needs of a given role (managers, trainers, IT personnel).
Traceability with electronic signatures on assessments and SOPs — Electronic signatures comprised of the signer information, including the First Name, Last Name, and User ID within the system, as required on electronic records.
Real-time reports for managers and administrators — Generate, customize and schedule your training, compliance and administrative reports in support of your qualification-based life sciences training program.
Record protections — Provides more than 250 audit trails, or log events, that capture the time stamp of when the activity occurred. Life sciences companies should maintain log events for many critical activities for audit purposes.
Role-based assignment functionality — Designed to support the creation of role-based groups and assignments to these groups. This dramatically reduces reliance on manual administrative reviews to identify who has the qualification for a speciﬁc role.
Secure integrations with essential enterprise systems — Integrates with document management systems, human resource management systems, manufacturing execution systems and single single-on providers to aid with streamlining your processes.
Version control of training items — Supports proper standard operating procedure (SOP) management and the versioning and retention rules that accompany each SOP.
Visibility into training status — Data structure and functionality of ComplianceWire® automates required qualiﬁcation for all employees engaged in GxP initiatives.
Course customization to address unique needs — Easily modify existing courses or create new courses with UL’s Create™ tool
The learning management technology used by the FDA
Since 1999, ComplianceWire®, and UL’s life science e-learning courses, have been the FDA’s trusted learning solution to train more than 40,000 global, federal, state and local investigators. The agency chose the ComplianceWire® platform as their training solution, ORA-U, the virtual university for FDA’s Office of Regulatory Affairs (ORA) infrastructure, 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 to train its inspectors and investigators in its virtual university are available exclusively to UL 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, 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.
UL’s extensive content libraries of life sciences-focused computer-based training courses
UL is the only LMS provider that also provides more than 400 standard regulatory and performance-focused course topics. These include, but are not limited to:
- GMP (Good Manufacturing Practices) and Quality
- FDA Inspections and Enforcements
- GCP (Good Clinical Practices)
- EHS (Employee Health and Safety)
- Ethics and Corporate Responsibilities
- HR Compliance and Risk Management
- Sales and Marketing
- Data Integrity
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. This training resource includes:
- More than 1,400 comprehensive and updated courses on compliance, safety and healthcare, including more than 110 co-developed with the FDA
- Standardized courses on issues regulated by federal agencies, including the Office of Inspector General, Securities and Exchange Commission, U.S. Environmental Protection Agency, Occupational Safety and Health Administration, and U.S. Department of Health and Human Services
- 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, CreateTM.
UL’s Create™ tool can help you with your unique learning requirements
Create is our authoring tool that makes it easy for you to efficiently author and publish new e-learning content for your workforce. The tool can be used to edit existing UL courses or to develop your own.
With Create, discover how to easily:
- Create a new course
- Add content
- Upload graphics
- Import videos
With Create’s easy-to-use interface, e-learning has never been simpler.