## [ComplianceWire®](/software/ultrus/compliancewire-lms) # ComplianceWire® Support compliance-critical workforce qualification with a validated, AI-enabled platform trusted by life sciences organizations worldwide and shaped by UL Solutions expertise, customer collaboration and the realities of regulated life sciences. [ Request a demo ](#form) [ Sign in ](https://www.compliancewire.com/CW3/Standard/Authentication/LogIn) ![Graphical depiction of progress in online learning courses](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:de11a316-c9d4-4fe1-8e7c-0cedef7a063a/as/de11a316-c9d4-4fe1-8e7c-0cedef7a063a.webp?&smartcrop=Landscape&max-quality=90&width=400) *play\_arrow* *pause* ## Breadcrumb - [ *keyboard\_arrow\_left* ULTRUS® Software Solutions: Power Resilient Growth ](/software/ultrus) - [ Home ](/) *pen\_size\_1* - Software *pen\_size\_1* - [ ULTRUS® Software Solutions: Power Resilient Growth ](/software/ultrus) *pen\_size\_1* - ComplianceWire® Close *cancel* ### Ready to boost your life sciences training and e-learning capabilities? Schedule a demonstration to learn how ComplianceWire can help you navigate complex regulatory requirements. \* By ticking this box, I confirm that I have read and understood the [Online Policy](https://www.ul.com/resources/online-policies) and consent to the processing of my personal data as described therein. \* By ticking this box, I consent to the cross-border transfer of my personal data as described in the [Online Policy](https://www.ul.com/resources/online-policies). I agree to receive UL Solutions marketing communications and understand that I can opt out at any time without affecting other services by visiting our [Preference Center](https://www.ul.com/preference-center). ##### Thank you! One of our team members will respond to your request as soon as possible. Close ![Computer webinar](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/computer_webinar.svg)800M+ Trainings delivered ![People group full body](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/people_group_full_body.svg)3.3M+ Users worldwide ![Globe](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/globe.svg)23 of 50 Top global life sciences companies use our software ![Checklist](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/checklist.svg)50+ Customer audits supported annually ![Laptop education](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/laptop_education.svg)400+ Life sciences e-learning courses ![Certification stamp](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/certification_stamp.svg)Built on 130+ Years of expertise from UL Solutions ## A purpose-built platform for compliance-critical workforce qualification In regulated life sciences, training records must offer more than proof of completion. They must also demonstrate that employees, contractors, suppliers and clinical teams are qualified to perform work that affects product quality, patient safety and regulatory compliance. ULTRUS® ComplianceWire® helps organizations manage these requirements with a validated, auditable platform enhanced by ULTRUS® AI and purpose-built for Good Practice (GxP) training and workforce qualification. The platform is organized around three commitments: Strengthen, Simplify and Partner. “We not only enable the health and life sciences industry to meet regulatory standards but also support a culture of quality, safety, and continuous learning.” ![Colleen LoConte](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:7ff8d383-bb1c-4add-aa89-ec3c75aacd6c/as/7ff8d383-bb1c-4add-aa89-ec3c75aacd6c.webp?&smartcrop=Square&max-quality=90&width=400) ### Colleen LoConte General Manager, ComplianceWire® ## Three commitments behind every deployment ![Key management](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/key_management.svg)### Strengthen compliance management Help satisfy qualification requirements with controlled, traceable records built to support FDA 21 CFR Part 11 and EU Annex 11. • Validated GxP training and workforce qualification software • FDA 21 CFR Part 11 and EU Annex 11 support • Audit trails and documentation support • Industry-leading course catalog ![Computer ai software](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/computer_ai_software.svg)### Simplify operations Improve operational efficiency by automating assignments and streamlining administration to help reduce manual effort. • Role-based training automation • Qualification matrices and qualification overviews • Scheduled reporting and targeted follow-up • AI-powered translation and AI-assisted assessments by ULTRUS® AI • Ready-to-deploy courses ![People group in shield](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/people_group_in_shield.svg)### Partner with proven experts Working with a partner shaped by customer collaboration and deep life sciences expertise. • In-house professional services and support • Client Advisory Boards (CABs) and structured feedback • 400+ expert-created e-learning courses • Global enterprise-scale deployment history ![A manager checking the training status of three employees](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:8170caa7-6076-4071-bc32-84bfbe4fa4fe/as/8170caa7-6076-4071-bc32-84bfbe4fa4fe.webp?&max-quality=90&width=400) ## A system purpose-built for regulated environments Reduce compliance exposure by maintaining controlled, traceable qualification records in a validated system designed to support regulatory requirements, including FDA 21 CFR Part 11 and EU Annex 11. ![](https://fast.wistia.com/embed/medias/q0er26dax3/swatch) *play\_circle* Watch Video Watch Video Duration ### Purpose-built for regulated life sciences organizations Built for regulated life sciences organizations worldwide, ComplianceWire® supports regulated training, role-based qualifications, audit trails and validation documentation across complex GxP environments. ### Industry-leading course catalog ComplianceWire® provides access to a comprehensive catalog of life science training content that supports GxP compliance, workforce qualification and continuous learning. The content is developed by industry experts and regularly updated to reflect evolving regulations and best practices. ### Audit-ready confidence When inspectors ask who performed regulated work and whether they were qualified, teams need evidence they can retrieve and defend. ComplianceWire® keeps qualification records controlled, traceable and accessible, helping teams generate audit-ready reports when needed. **Trusted by life sciences** - FDA 21 CFR Part 11 and EU Annex 11 support - GxP training and workforce qualification - Audit trails and documentation support - Purpose-built workflows for quality and compliance teams - Applicable across pharmaceutical, medical device, clinical and supplier operations - Industry-leading life sciences course catalog ![Person using ComplianceWire to complete a course](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:2efd0d1b-d016-45ec-bee9-e6476588a892/as/2efd0d1b-d016-45ec-bee9-e6476588a892.webp?&smartcrop=Landscape&max-quality=90&width=400) ## Less administrative burden. More consistent execution. Improve operational efficiency by automating training assignments and streamlining administration, supporting timely qualification with fewer manual steps. ![Illustration showing the status of suppliers, employees, and clinical trials in order to be audit ready](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:5a517305-2f64-4958-9c27-0f2e09e14843/as/5a517305-2f64-4958-9c27-0f2e09e14843.webp?&smartcrop=Landscape&max-quality=90&width=400) ### Automate compliance administration Automate training assignments, qualification workflows, reporting and follow-up activities to help reduce administrative burden, improve visibility and support more consistent compliance execution across teams, sites and business processes. ### Responsible modernization ComplianceWire® is part of the ULTRUS® AI-powered platform, incorporating intelligent reporting and workflow improvements designed to help reduce manual effort and improve insight. ### Integration and data enablement Connect compliance training data with other systems and reporting environments. APIs and integrations help teams use qualification insights more effectively while preserving validated-record integrity. ### Ready to deploy course catalog Ready-to-deploy courses support GxP training requirements, enabling greater consistency and more efficient use of internal training resources. **Trusted by life sciences** - Role-based training automation - Qualification matrices and qualification overview - Scheduled reporting and targeted follow-up - Configurable forms, smart forms and segmented workflows - AI-enabled translation and AI-powered assessment creation - Intelligent reporting, data enablement and integration support - Human-in-the-loop modernization for validated environments - Foundational compliance training catalog ## More than software — specialized expertise at your side Build confidence in compliance-critical workforce qualification by working with a partner that combines UL Solutions’ expertise, long-standing customer collaboration, in-house support and deep life sciences experience. ![Person selecting a training course from ComplianWire's course library](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:3fef1430-7955-4ead-834e-56fd9d628017/as/3fef1430-7955-4ead-834e-56fd9d628017.webp?&smartcrop=Landscape&max-quality=90&width=400) ### Specialized in-house expertise ComplianceWire® combines purpose-built technology with experienced specialists. In-house professional services, implementation and support teams help customers navigate validation, audit expectations and qualification management at scale. ### Built alongside the organizations that depend on it ComplianceWire® evolves through active collaboration with the customers who rely on it. CABs, focus groups and enhancement requests keep the road map grounded in real compliance challenges, not software trends. ### Trusted to perform at scale Deeply rooted in regulated life sciences, ComplianceWire® has a proven record of supporting complex global organizations. That scale and audit history provide additional context for organizations evaluating qualification systems. ### Expert-created content ComplianceWire® supports life sciences training with expert-created content, SME-informed course development and training resources shaped by years of experience with industry expectations and regulated pharmaceutical and medical device practices. ### Content informed by regulatory and industry expertise Expert-created content and SME-informed courses are shaped by years of experience with FDA expectations and regulated pharmaceutical and medical device practices. ComplianceWire® supports workforce readiness while helping organizations move beyond simply tracking course completions. **Trusted by life sciences** - In-house professional services, implementation and support - Validation expertise and audit support experience - CABs, focus groups and structured enhancement processes - Customer-informed road map and controlled release cadence - High-volume training history and global enterprise-scale deployments - Expert-created life sciences e-learning courses and content development support - Training content informed by SMEs and long-standing experience with FDA expectations - Flexible integration capabilities to support connected learning environments ## Engineered for life sciences and clinical operations ### Life sciences organizations - Manage GxP training, workforce qualification and audit readiness across regulated operations - Assign role-based training and track qualification status - Maintain traceable, auditable records instead of manual reporting or disconnected systems - Support quality, compliance, regulatory and training teams in one validated system ### Clinical organizations - Gain oversight into who is qualified across studies, trial sites and protocols - Identify gaps and follow up on corrective and preventive actions (CAPAs) - Respond to audits and regulatory inquiries with confidence - Reduce duplicated effort across clinical, quality, compliance, learning and IT teams ![Person using ComplianceWire to make sure their documents are audit ready](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:477f8354-bd4f-4b97-a980-59b99a6c27c2/as/477f8354-bd4f-4b97-a980-59b99a6c27c2.webp?&smartcrop=Landscape&max-quality=90&width=400) ## ComplianceWire Customer Testimonials ![ULTRUS ComplianceWire Customer Testimonial - Mérieux Melanie Stephenson 1](https://fast.wistia.com/embed/medias/9ovxqkdkgv/swatch) *play\_circle* Watch Video ULTRUS ComplianceWire Customer Testimonial - Mérieux Melanie Stephenson 1 Duration ![ULTRUS ComplianceWire Customer Testimonial - Mérieux Melanie Stephenson 2](https://fast.wistia.com/embed/medias/gimnpaw6cm/swatch) *play\_circle* Watch Video ULTRUS ComplianceWire Customer Testimonial - Mérieux Melanie Stephenson 2 Duration ![ULTRUS ComplianceWire Customer Testimonial - Mérieux Melanie Stephenson 3](https://fast.wistia.com/embed/medias/q0b8csvfkp/swatch) *play\_circle* Watch Video ULTRUS ComplianceWire Customer Testimonial - Mérieux Melanie Stephenson 3 Duration ![UL Solutions Abstract Graphics - Full Circuit](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:32ecb06c-71b5-4dab-9963-748f891ed6a2/as/32ecb06c-71b5-4dab-9963-748f891ed6a2.webp?&max-quality=90&width=400) ![UL Solutions](/modules/custom/ul_component/components/brand_element/assets/brand-element-positive/mobius.svg) ![UL Solutions](/modules/custom/ul_component/components/brand_element/assets/brand-element-reverse/mobius.svg) ## See how ComplianceWire® supports your next audit ComplianceWire® is a purpose-built GxP training and workforce qualification platform that helps regulated life sciences and clinical organizations document readiness, support inspection preparedness and manage compliance-critical training with confidence. [ Request a demo ](#form) ## Frequently Asked Questions ### We already have an enterprise learning management system (LMS). Why do we need ComplianceWire® too? *add* *remove* A: Many organizations want to consolidate learning into a single LMS. For compliance-critical GxP training, however, clarity, validation, traceability and inspection-ready evidence matter more than broad learning administration. ComplianceWire® integrates with your enterprise ecosystem while preserving a focused system of record purpose-built to maintain the qualification evidence needed to withstand regulatory scrutiny. ### How does ComplianceWire® support FDA 21 CFR Part 11 and EU Annex 11 requirements? *add* *remove* ComplianceWire® is a validated system designed to support FDA 21 CFR Part 11 and EU Annex 11 requirements, giving pharmaceutical, medical device, clinical and other GxP operations the structure, traceability and audit-ready documentation needed to demonstrate workforce readiness and maintain inspection preparedness at enterprise scale. ### Is ComplianceWire® investing in AI and modernization? *add* *remove* Yes, responsibly. ComplianceWire® is investing in AI, intelligent reporting, data enablement, forms, assessments, APIs and workflow improvements designed to help reduce manual effort and improve insight. Human oversight remains central as organizations adopt new capabilities. ### How is the ComplianceWire® road map shaped? *add* *remove* ComplianceWire® evolves through active collaboration with the customers who depend on it. Client Advisory Boards (CABs), focus groups, enhancement requests and ongoing product collaboration help keep the road map grounded in real compliance challenges. ### What types of regulated industries typically use ComplianceWire®? *add* *remove* ComplianceWire® is designed for global organizations operating in highly regulated environments, particularly within the life sciences. This includes pharmaceutical, biotechnology and medical device organizations, such as contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), and biologics companies, as well as organizations that must comply with Good Practice (GxP) requirements and global regulatory expectations. ### Can ComplianceWire® integrate with other enterprise systems, such as HRIS or document management tools? *add* *remove* Yes. ComplianceWire® is system-agnostic and built to fit within the systems already being used by your organization. The software is designed to integrate with a wide range of enterprise systems, including human resources information systems (HRIS), document management systems, and other learning or business platforms. This compatibility helps streamline user management, training assignments and document distribution across the organization. ### Why shouldn’t we just build our own LMS for regulated training? *add* *remove* While building an internal LMS is technically possible, life sciences organizations face requirements that extend beyond developing training functionality. They also need to validate the system, maintain CFR Part 11-compliant audit trails and electronic signatures, support regulatory inspections, manage ongoing revalidation and sustain the platform with dedicated engineering, quality and compliance resources. For many organizations, a purpose-built platform like ComplianceWire® offers a lower-risk and potentially more cost-effective approach. It is designed specifically for regulated training, includes audit-ready capabilities and enables teams to focus on quality and compliance objectives rather than the ongoing burden of maintaining a regulated software platform. ### How does ComplianceWire® help organizations prepare for audits or regulatory inspections? *add* *remove* ComplianceWire® supports audit and inspection readiness by maintaining validated electronic records, secure audit trails, and detailed training and qualification histories. The system generates standard reports commonly requested by regulatory authorities and enables organizations to quickly demonstrate employee training status, qualifications and compliance with applicable regulations. ### Does ComplianceWire® support role-based or automated training assignments? *add* *remove* Yes. ComplianceWire® enables automated, role-based training assignments using configurable learner attributes, including role, department, location or other organizational criteria. As employee roles or attributes change, training assignments can be updated automatically to help maintain ongoing compliance. ### What scalability options does ComplianceWire® offer for growing organizations? *add* *remove* ComplianceWire® is built to scale with organizations as they grow, supporting complex organizational structures across multiple locations while providing extended enterprise learning capabilities for contractors, partners or suppliers. The platform is designed to accommodate increasing numbers of users, training programs and regulatory requirements without compromising performance or compliance oversight. ### What reporting and analytics features does ComplianceWire® include? *add* *remove* ComplianceWire® provides real-time dashboards and reporting tools that give administrators and managers visibility into training completion, qualification status and compliance gaps. Reports can be used to monitor trends, identify risks, support internal and external audits, and address regulatory inquiries. ### What type of support does UL Solutions provide during the implementation of ComplianceWire®? *add* *remove* UL Solutions has a highly tenured in-house team with deep expertise developed through hundreds of ComplianceWire® implementations and system validations. Because our team understands the system deeply, it provides responsive, hands-on support throughout implementation, helping organizations streamline deployment and adoption. ## Related content ![Brown medicine glass bottles on production line.](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:4c48e040-954e-4cb3-b8d2-55b82f480ba9/as/4c48e040-954e-4cb3-b8d2-55b82f480ba9.webp?&max-quality=90&width=400) Offering ### ComplianceWire® e-Learning Library for Life Sciences Discover the unique advantage of ComplianceWire® to help you comply with U.S. Food and Drug Administration (FDA) regulation of medical devices and pharmaceuticals. Our course catalog contains more than 400 life sciences e-learning courses. [ Learn more *arrow\_forward* ](/software/compliancewire-elearning-content-suggested-courseware) ![Paperless workplace ideas, e-signing, electronic signature, document management. A businessman uses a stylus pen to sign an electronic document that is on the screen of a virtual notebook.](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:b1e8e83c-48cc-4322-8539-ca9e49ccfad1/as/b1e8e83c-48cc-4322-8539-ca9e49ccfad1.webp?&max-quality=90&width=400) Article ### Advanced Qualification Form Workflows ULTRUS® ComplianceWire® digitizes complex qualification steps with automated workflows. Secure e‑signatures and real‑time, audit‑ready visibility — replacing paper processes and manual routing. [ Learn more *arrow\_forward* ](/insights/advanced-qualification-form-workflows) ![compliance-wire-ultrus](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:5322973a-6584-4600-a002-8e0d0a722ca8/as/5322973a-6584-4600-a002-8e0d0a722ca8.webp?&max-quality=90&width=400) ### ULTRUS® ComplianceWire® June 2026 Release This release is designed to support global workforce qualification through intuitive design and AI-enabled capabilities. [ Learn more *arrow\_forward* ](/insights/ultrus-compliancewire-june-2026-release) ![ULTRUS](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:89b89dea-86ad-44bc-a9bc-512915fd1f50/as/89b89dea-86ad-44bc-a9bc-512915fd1f50.webp?&max-quality=90&width=400) Offering ### ULTRUS™ ComplianceWire® Clinical Qualification Learn how ComplianceWire® Clinical Qualification helps manage clinical ecosystem qualifications and trainings. [ Learn more *arrow\_forward* ](/software/ultrus/ultrus-compliancewire-clinical-qualification) ![Science, teamwork and scientist with tablet in laboratory for communication, pharmaceutical review or planning. Employees, collaboration and technology for research, discussion and digital analysis](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:ceb51c22-0e29-4cd8-9a0f-0938958a0418/as/ceb51c22-0e29-4cd8-9a0f-0938958a0418.webp?&max-quality=90&width=400) ### ULTRUS® ComplianceWire®: Shaping the Future of Workforce Training in Life Sciences Discover how ULTRUS ComplianceWire is evolving to help life sciences organizations enable workforce qualification, strengthen compliance and prepare for the future of regulated training. [ Learn more *arrow\_forward* ](/events/ultrus-compliancewire-shaping-future-workforce-training-life-sciences) ![Tablet, reading and woman scientist in laboratory working on medical research, project or experiment. Science, career and female researcher with digital technology for pharmaceutical innovation.](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:7b50a383-3411-49e8-a776-9811b518df71/as/7b50a383-3411-49e8-a776-9811b518df71.webp?&max-quality=90&width=400) ### What's New and Next for ULTRUS® ComplianceWire Join the ULTRUS® ComplianceWire® product team for a look at our product strategy, recent innovations, and future roadmap for life sciences training and compliance. [ Learn more *arrow\_forward* ](/events/whats-new-and-next-ultrus-compliancewire) ![Tablet, reading and woman scientist in laboratory working on medical research, project or experiment. 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