Support validated GxP training management, qualification tracking, content creation and auditable reporting in a single, purpose-built environment.
Training and qualification gaps persist in life sciences. In the UL Solutions 2024 Life Science Learning Benchmark Study, leaders cite a range of challenges in their regulated organizations, including:
Support safer and more effective medical products with ULTRUS® Compliant Workforce Qualification. Scale training to meet regulatory and industry standards — via our 21 CFR Part 11 and EU Annex 11 validated system.
As part of the ComplianceWire® Learning and Qualification Management System, this tool helps you automate training and implement stronger risk management practices.
Scale quality and compliance across your business, including supply chain and clinical trial qualifications.
Compliant Workforce Qualification helps streamline and automate your employee qualification processes.
Track, monitor and share the status of your employees in meeting their required qualifications and training in aggregate — or drill into the areas where improvement possibilities and risk are identified.
Demonstrate through audit trails the completion of qualifications, commitments and other regulatory obligations.
Strengthen workforce knowledge through the ComplianceWire® e-Learning Library for Life Sciences. Designed to support compliance with U.S. Food and Drug Administration (FDA) regulations, this catalog contains more than 400 life sciences courses — many of which were co-developed with the FDA.
Leverage ULTRUS® Course Create, our easy-to-use content authoring tool, to scale content creation. Get important knowledge to your workforce faster and create, modify and scale across your business efficiently.
Support safer and more effective medical products with ULTRUS® Compliant Workforce Qualification. Scale training to meet regulatory and industry standards — via our 21 CFR Part 11 and EU Annex 11 validated system.
As part of the ComplianceWire® Learning and Qualification Management System, this tool helps you automate training and implement stronger risk management practices.
Scale quality and compliance across your business, including supply chain and clinical trial qualifications.
Compliant Workforce Qualification helps streamline and automate your employee qualification processes.
Track, monitor and share the status of your employees in meeting their required qualifications and training in aggregate — or drill into the areas where improvement possibilities and risk are identified.
Demonstrate through audit trails the completion of qualifications, commitments and other regulatory obligations.
Strengthen workforce knowledge through the ComplianceWire® e-Learning Library for Life Sciences. Designed to support compliance with U.S. Food and Drug Administration (FDA) regulations, this catalog contains more than 400 life sciences courses — many of which were co-developed with the FDA.
Leverage ULTRUS® Course Create, our easy-to-use content authoring tool, to scale content creation. Get important knowledge to your workforce faster and create, modify and scale across your business efficiently.
Manage the clinical performance qualifications of your healthcare professionals and reduce duplicative training. Track and monitor the status of your qualified workforce and site study personnel. Review employees’ required qualifications in aggregate, or focus on areas where improvements and risk management are needed.
Compliant Workforce Qualification was purpose-built for life sciences companies and used by the FDA to improve quality, minimize risk and support product safety.
An audit-ready solution, this software is validated to 21 CFR Part 11 and EU Annex 11 requirements, with trusted audit, reporting and traceability features.
With role-based training, automation, enterprise integration, and global scale, Compliant Workforce Qualification helps regulated industries maintain compliance, minimize risk and be inspection-ready.
“We not only enable the health and life sciences industry to meet regulatory standards but build a culture of quality, safety, and continuous learning.”
Compliant Workforce Qualification software unifies training management, qualification tracking, content creation and audit reporting in a validated environment. You can assign training by role, monitor qualifications in real time, automate recurring tasks, author or adapt courses and output audit‑ready reports with full transparency.
Yes. ComplianceWire® is an off-the-shelf software-as-a-service (SaaS) offering hosted by UL Solutions. This platform is a 21 CFR Part 11 and EU Annex 11 validated system. Validation documentation is provided for each major release and full audit trails to support inspection readiness.
ULTRUS® ComplianceWire® contains commonly requested regulatory reports, provides complete audit trails and provides quick access to validation documentation.
UL Solutions provides 400+ life sciences courses, many co‑developed with the FDA, and ULTRUS® Course Create lets organizations augment modules or build SCORM‑compliant courses tailored to company needs and branding.
ComplianceWire® is proven at enterprise scale, supporting over 3.3 million active learners across more than 700 sites in 130+ countries, with more than 800 million training completions recorded. It is available in multiple languages and offers Europe-based data hosting to meet regional requirements.
Yes. ComplianceWire® can be configured to manage and track qualifications for contractors, suppliers and clinical trial roles, extending quality and compliance controls beyond manufacturing into your wider supply chain.
ComplianceWire® provides API suites for curricula and user groups that support automation of assignments and user management. Teams can also use builtin capabilities such as rolebased assignments, scheduled reports and targeted training pushes to reduce manual effort. Typical implementations include integrations for single sign-in (SSO), human resources and electronic document management systems (EDMS).
