Veeva Systems announced it will launch Veeva Vault Registrations, a comprehensive solution to manage product registration data worldwide, including registration status, variations, and health authority interactions. Veeva is previewing Vault Registrations at this week’s Drug Information Association eRegulatory and Information Conference. The new offering will be part of Veeva’s regulatory information management (RIM) suite that will also include Vault Submissions and Vault SubmissionsArchive.
A large life sciences company can have upwards of 400,000 registrations around the world for different products, indications, packages, and formulations. Typically, its regional affiliates use multiple tools for registration management and rely upon manual processes to bridge the gaps, resulting in redundant or missing information. Disconnected, difficult-to-use systems impede companies’ ability to manage product registrations, health authority interactions, and compliance, according to research by Gens & Associates.
“We are pleased to announce the first cloud solution for global registration management,” said John Lawrie, Director of Veeva Vault RIM. “Veeva Vault Registrations addresses the significant need for a single system that is easy to use, accessible to affiliates worldwide, and provides complete visibility. With Vault Registrations, companies can speed time to market by quickly understanding the impact of product introductions and proposed product changes.”
Vault Registrations is part of the upcoming Veeva Vault RIM suite of applications to manage product and registration information, submission documents, and published dossiers. Veeva Vault RIM will provide a seamless and integrated approach to regulatory information management and includes:
- Vault Registrations for management, tracking and reporting of product and registration information globally, including approval status, variations, health authority questions and commitments, and certification requests. Planned for release in the first quarter of 2016.
- Vault Submissions for authoring, reviewing, approving, and managing the assembly of submission documents, also for tracking and exchanging documents between headquarters and affiliates. Available now.
- Vault SubmissionsArchive for storing published submissions in a secure, globally accessible repository with integrated document navigation and eCTD submission viewing capabilities. Planned for release in the first quarter of 2016.
Vault Registrations will be available as a stand-alone product, or as part of the Veeva Vault RIM suite.