
ComplianceWire Learning Management System Brochure
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.
ComplianceWire integrates these critical components:
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 Solutions’ Create™ tool
Since 1999, ComplianceWire®, and UL Solutions’ 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 Solutions 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 Solutions customers.
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 Solutions 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:
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:
The ability to customize or create new training content, working with UL Solutions’ design team or through our course self-authoring tool, CreateTM.
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 Solutions courses or to develop your own.
With Create, discover how to easily:
With Create’s easy-to-use interface, e-learning has never been simpler.
ComplianceWire Learning Management System Brochure