Veeva Systems, a cloud-based software provider for the global life sciences industry, has launched Veeva Vault RIM, a next-generation regulatory information management (RIM) suite. Vault RIM unites submission documents, published dossiers, product registrations and health authority interactions into a single authoritative source for all regulatory information. The convergence of RIM capabilities in Veeva Vault’s regulatory product suite will align disconnected regulatory processes worldwide, dramatically improving life sciences companies’ speed, agility and compliance.
Today, regulatory information is captured in a multitude of disconnected central and local systems that manage everything from product registrations, regulatory events, submissions, health authority correspondence and commitments, published dossiers and more. Industry research has found the majority of companies have identical and related information in multiple systems around the globe, creating redundancies and significant duplication of efforts worldwide.
“Disconnected information and systems are among the biggest hurdles that regulatory faces today,” said Steve Gens, managing partner at Gens and Associates and presenter at Veeva’s R&D Summit. “This inefficiency significantly hinders regulatory productivity and the ability to have a real-time, end-to-end, regulatory picture.”
Vault RIM is the first suite of regulatory applications to seamlessly manage both content, such as documents, and data, like registrations and events. Vault RIM eliminates the artificial division between content and data imposed by traditional systems, and removes the need for companies to purchase and integrate a multitude of disparate systems, thereby reducing cost and complexity. Further, by centralizing registration-related information across all geographies, companies can eliminate duplicate data entry and automate many of the manual, repetitive steps slowing today’s processes.
The Vault RIM suite of applications includes Veeva Vault Submissions, Veeva Vault SubmissionsArchive, and Veeva Vault Registrations. Vault Submissions manages the planning, authoring, review and approval of documents for submission to regulatory authorities. Vault SubmissionsArchive stores published submissions in a secure, globally accessible repository with integrated document navigation and eCTD submission viewing capabilities. Vault Registrations also enables efficient management, tracking and reporting of product and registration information globally, including approval status, variations and health-related authority questions and commitments.