Veeva Systems this week 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 modernise 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 source for submission documents, published dossiers, health authority interactions and product registrations. With Vault RIM, life sciences companies 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 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 organisations drive end-to-end business processes across R&D and manufacturing.
To learn more about how leading life sciences organisations are modernising their regulatory processes and system, visit Veeva at booth #21 at eRegulatory Summit in Barcelona, Spain, 8 - 10 April.
