Veeva Systems

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

Barcelona, Spain (ots/PRNewswire) - Next-generation product suite aligns regulatory processes, driving speed, agility, and

compliance  

Veeva Systems kicked off its annual 2015 R&D Summit today with the launch of Veeva Vault RIM [https://www.veeva.com/products/rd-cloud/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.

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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 systems[1] 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. "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 [https://www.veeva.com/products/rd-cloud/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 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 [https://www.veeva.com/resources/veeva-systems-unveils-first-fully-integrated-clinical-trials-study-start-up-solution] application 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.

Additional Information 

 
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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 http://www.veeva.com/eu.

Forward-looking Statements 

This release contains forward-looking statements, including the market demand for and acceptance of Veeva's products and services, the results from use of Veeva's products and services, and general business conditions, particularly in the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva's historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva's expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva's financial results are included under the captions, "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the company's filing on Form 10-Q for the period ended July 31, 2015. This is available on the company's website at http://www.veeva.com/eu under the Investors section and on the SEC's website at http://www.sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.

[1] Gens & Associates, Next Generation Regulatory Information Management and Intelligence: Strategy, Investments, and Status, 2014.

 
Contacts: 
Sue Glanville / Cate Bonthuys 
Veeva Systems Inc. 
sue@catalystcomms.co.uk / cate@catalystcomms.co.uk 
 

 


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