Noverant Completes Validation of Enterprise 3 Service for Life Science and Pharmaceutical Industries
RALEIGH, NC – Noverant, a leading provider of information, training and compliance management services for FDA-regulated companies, completed formal validation of its latest web-based learning management system. The validation enables existing and new clients to shift to Noverant's industry-leading service while minimizing the burden associated with traditional 21 CFR 11 validation efforts.
Software validation requires a rigorous sequence of tests including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) that consume significant resources any time a system is upgraded. Noverant has successfully completed the full validation of the newest release in the company's QA-controlled environment which is hosted in Noverant's state-of-the-art data center. The validation provides the required core documentation that demonstrates evidence of compliance to system specifications and 21 CFR 11.
Once validation is complete in Noverant's environment, Noverant then works with individual clients to effectively transfer the documented OQ testing results in an efficient, FDA-approved framework to the client's dedicated instance.
Noverant offers its service for FDA-regulated industries in a variety of deployment options, ranging from dedicated on-site installations to private cloud instances administered by Noverant. Commenting on the recent validation, Jim Tringas, VP of Global Marketing at Noverant stated: "Noverant Online Enterprise 3 brings unprecedented functionality including incredible learner usability, real-time analytics, an advanced reporting engine and universal mobile access. Completing the validation process enables our life science clients to take advantage of the rich new user interface while easily adhering to 21 CFR 11 standards.”
Noverant Online Enterprise 3 is currently used in a wide variety of industries on six continents for clients ranging from small physician offices to international pharmaceutical giants.