Veeva to launch global registrations management solution
California-based Veeva Systems will launch Veeva Vault Registrations, a comprehensive solution to manage product registration data worldwide, including registration status, variations and health authority interactions. The new offering will be part of Veeva’s regulatory information management (RIM) suite that also will include Vault Submissions and Vault SubmissionsArchive.
A large life sciences company can have upward 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.
Katrin Spaepen, director of Veeva Vault RIM, Europe, said, "In providing real-time data tracking and reporting, companies can speed time to market by quickly understanding the impact of product introductions and proposed product changes."
Global registration management is increasingly important for Europe as the EMA introduces the Identification of Medicinal Products (IDMP) standards for the unique identification of medicines and the exchange of information on medicines. By July 2016, life sciences companies are required to submit product relevant information so health authorities can simplify the exchange of data across the world to enhance patient safety.
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. It is planned for release in the first quarter of 2016.
- Vault Submissions for authoring, reviewing, approving and managing the assembly of submission documents, as well as 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. It is planned for release in the first quarter of 2016.
Vault Registrations will be available as a standalone product, or as part of the Veeva Vault RIM suite.