Leading organizations are choosing Vault RIM for a single authoritative source of content and data
to improve regulatory business operations and compliance
BETHESDA, MD — DIA Regulatory Submissions, Information, and Document Management (RSIDM) Forum — Feb. 12, 2019 — Veeva Systems (NYSE:VEEV) today announced increasing numbers of life sciences companies are adopting applications in Veeva Vault RIM, the first unified suite of RIM applications on one cloud platform, to modernize their regulatory processes and systems. More than 150 companies are implementing Vault RIM applications, including four of the top 10 largest global pharmaceutical companies, to streamline submission development and provide greater visibility across end-to-end processes.
Vault RIM brings together regulatory content and data on a single platform so teams have one authoritative source for submission documents, published dossiers, health authority interactions, and product registrations. With Vault RIM, life sciences companies can eliminate the need for multiple systems and manual tracking that slow execution and increase compliance risk.
The latest addition to the Vault RIM suite of applications, Veeva Vault Submissions Publishing, is a new approach that brings together publishing activities with document planning, authoring, and approval in a single system to streamline the entire submission development process. This enables customers to significantly speed regulatory submission preparation and delivery. Melinta Therapeutics, for example, cut its submission development time in half and published 100 submissions within the first two months of using Vault Submissions Publishing.
Vault Submissions Publishing enables a continuous publishing process to finish publishing steps sooner so validation issues are identified and fixed faster for greater efficiency and improved compliance. Continuous publishing eliminates the manual movement of documents between multiple systems and reduces the number of document transfers to one – when the dossier is transmitted directly to the health authority.
“With a continuous publishing model, regulatory teams can identify any errors and address broken links to source data as the submission is being built so teams don’t have to go through the lengthy republishing process over and over,” said Shelly Plapp, director of regulatory operations at Melinta. “By the time you are ready to publish, the submission is already quality checked and correct.”
“Veeva innovation is transforming RIM globally across the life sciences industry,” said John Lawrie, vice president, Veeva Vault RIM. “Melinta is a great example of how companies can benefit from a single unified system that streamlines regulatory activities to speed submissions.”
Veeva Vault RIM Suite includes Vault Registrations, Vault Submissions, Vault Submissions Publishing, and Vault Submissions Archive. Vault RIM is part of Veeva Development Cloud, a unified suite of applications for clinical, regulatory, and quality to help organizations drive end-to-end business processes across R&D and manufacturing.
Join Veeva and Melinta at the DIA RSIDM Forum on Feb. 12, from 1:20 p.m. – 1:35 p.m., in the Solution Showcase Theater, to learn more about how Melinta accelerated end-to-end submission development.
For more on continuous publishing, read the article, “How Continuous Publishing Speeds Regulatory Submissions,” in DIA Global Forum.
For more on Veeva Vault RIM Suite, visit: veeva.com/RIM
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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 675 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America. For more information, visit veeva.com.
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 October 31, 2018. This is available on the company’s website at veeva.com under the Investors section and on the SEC’s website at 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.