New RIM Solution Unites Registration Information, Documents, and Dossiers to Transform Regulatory Globally

SOURCE: Veeva Systems

PHILADELPHIA, PA — Nov. 2, 2015 — Veeva Systems kicked off its annual 2015 R&D Summit today with the launch of 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, to published dossiers and more. Industry research has found the majority of companies have identical and related information in multiple systems¹ 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.

“With the Veeva Vault RIM suite, companies can unify regulatory information for a fully integrated view and greater control over agency correspondence and commitments, ” said John Lawrie, director of Veeva Vault RIM. “This visibility and efficiency can increase alignment and agility across an organization. ”

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. And, Vault Registrations enables efficient management, tracking, and reporting of product and registration information globally, including approval status, variations, and health-related authority questions and commitments.

“Veeva is ushering in the next generation of RIM solutions, replacing fragmented and outdated technologies to fundamentally change how regulatory teams collaborate around the world,” concluded Lawrie. “By bringing documents and data together in one, easy-to-use system, Vault RIM will transform the submissions process.”

Vault Submissions has been generally available since 2013. Veeva Vault SubmissionsArchive, and Veeva Vault Registrations, which round out the RIM suite, will be available in December 2015.

Also announced today at the 2015 Veeva R&D Summit, the Veeva Vault Study Start-Up application, which manages both the content and activities associated with onboarding investigative sites for clinical trials. The solution accelerates the critical time to enrolling the first patient for the first visit.

About Veeva Vault

Veeva Vault is the first cloud-based regulated content management platform and suite of applications designed for life sciences. It spans clinical, quality, commercial, medical, regulatory, and every major part of a global life sciences company to ensure one trusted source for content and data across the enterprise. Helping companies connect securely in the life sciences cloud, Vault provides complete control from start to finish, as well as the easy accessibility, visibility, and agility needed to speed time to market. All Vault applications offer real-time reporting and dashboards; an intuitive, consumer-web interface; and a true multitenant cloud architecture that continuously delivers rapid innovation. Today, more than 190 customers rely upon Vault to manage their most important content.

About Veeva Systems

Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 300 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit www.veeva.com.

Forward-looking Statements

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