03 January, 2022 – Navitas Life Sciences, a technology-backed global Clinical Research Organization (CRO) and UL, the global safety science leader, today announced that the two companies have joined forces to provide life sciences organizations with Learning Management Systems (LMS) to help optimize operational efficiency and meet regulatory compliance through learning management.
Through this partnership, Navitas Life Sciences will serve as an authorized distributor of UL’s ComplianceWire®, the industry-leading compliance training LMS specializing in life sciences organizations and compliant with 21 CFR Part 11 and EU Annex 11 validation requirements. ComplianceWire® 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. Since 1999, ComplianceWire®, as well as UL’s Life Science e-learning courses, have been the trusted learning solution used by the U.S. Food and Drug Administration (FDA) to train more than 40,000 global, federal, state and local investigators.
“With regulatory requirements becoming more complex and global in scope, we believe that our collaboration with Navitas Life Sciences will help empower the life sciences industry to deliver proactive compliance under the FDA and other regulatory bodies worldwide, and to bring medical device and pharmaceutical products to market safely,” said Jim O’Keefe, Director and General Manager of UL’s ComplianceWire®.
With a rich legacy of experience and expertise in the implementation of systems for the life sciences industry, Navitas Life Sciences serve as trusted advisors and provide tailored solutions grounded in industry best practices. Navitas Life Sciences’ experience includes the implementation of GxP compliant solutions for both regulatory and pharmacovigilance for more than 250 active customers across the globe, driving accelerated compliance and delivering first-time-right submissions.
“Life science companies consider learning management as a function that is quintessential to providing deeper insight, higher operational efficiency and optimal regulatory compliance across the organization,” said Marty Boom, Global Head of Regulatory and Safety at Navitas Life Sciences. “Such organizations look for a robust learning management system implemented by a partner who has rich experience and expertise in the life sciences domain. Navitas Life Scences and UL together fulfill this requirement, and that is why we are delighted to partner with UL’s ComplianceWire®.”
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