Managing the clinical ecosystem in ULTRUS™ ComplianceWire®
ULTRUS Learning from UL Solutions delivers proven turnkey learning solutions from trusted experts through our ComplianceWire platform that help minimize risk and provide safety, quality and compliance neccessary for succesful business performance.
Access secure environment and robust interface
Identify your clinical ecosystem
Define training requirements
Utilize dynamic reporting qualification and metrics tracking
Automate role-based assignments and reduce training overlap
Elevate compliance within the clinical ecosystem to meet regulatory requirements and industry standards
Maintain compliance to meet regulatory requirements and industry standards. Get the insight needed to monitor that your clinical ecosystem is qualified, informed and equipped to contribute to the safety of pharmaceuticals for patients.
Gain insight into your clinical ecosystem
Track and monitor the status of your clinical studies and site personnel. Review their required qualifications in aggregate, or drill down into areas where improvements and risk management are needed.
Align training requirements with clinical roles
This enables specific content to be distributed once to all individuals according to the organization’s particular structure.
Clinical ecosystem qualification overview
Dashboards and reports provide a region/study/site-wide view on compliance and qualification status at a glance.
Clinical ecosystem matrix
Drill down into each study or site and qualification in real time to understand exactly what is missing that is preventing compliance.
Streamline and automate the qualification and compliance process that effectively controls your clinical network
Easily communicate with and monitor your studies and sites, follow up on post-audit findings such as corrective and preventative actions (CAPAs), recalls and other regulatory obligations. ULTRUS ComplianceWire Clinical Qualification can be configured to support your specific ecosystem. Upload training, qualification and policies to maintain compliance.
Clinical ecosystem communications
Manage forms, agreements and certifications guaranteeing that studies and sites are utilizing qualified personnel, all in one location.
Automate qualification
Scale your training with our quality and compliance courses, 150 of which were developed in direct collaboration with the U.S. Food and Drug Administration (FDA). Or, easily create and distribute your own.
Fully configurable
Create different mechanisms for standards for meeting compliance and build out group hierarchies for better visibility.
Be ready to respond to an audit or regulatory inquiry
Stringent regulatory requirements are not only laid out to studies or sites but also the systems and processes used to support accuracy. ULTRUS ComplianceWire is natively compliant with 21 CFR Part 11 standards, equipped with a system that not only prepares for rigorous audits but also upholds compliance expectations.
Validated system
Learn how UL Solutions verifies every major release of ComplianceWire, with insights from our strategic advisory experts.
Audit readiness
Standard, audit-ready reports for quick, confident response to local, state and federal requests.
Tried and tested
ULTRUS ComplianceWire is regularly audited internally and by our customers. On average, ComplianceWire is audited over 50 times a year by our customers using paper, remote and onsite audits.
WHITE PAPER
Advancing Clinical Compliance and Qualification
ULTRUS ComplianceWire addresses industry needs with an automated system that simplifies processes for end users and administrators, providing a clear audit trail for supplier controls.
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