Veeva RegulatoryOne is a comprehensive, cloud-based family of applications used to unify regulatory documents, registrations, compliance, dossier, and claims management and can be used to manage interactions with competent authorities for the purpose of selling products in regulated markets. RegulatoryOne is built on Veeva Vault and includes the features described in Veeva Vault Help for Platform.
RegulatoryOne applications can be used alone or together within a single Vault.
- Compliance Management helps users manage and complete regulatory requests and track responses.
- Registration & Dossier Management helps users manage and track dossier, product registration, and certification status.
- Regulatory Documents helps users manage documents in relation to specific contexts such as products, formulas, and studies.
- Veeva Claims helps users manage the development, review, and approval of product claims.
Shared Data Model
RegulatoryOne applications share some common objects, which allows you to consolidate data for all of these applications in a single Vault. You can access a Data Model Documentation file that includes all standard objects for your Vault’s application family, and Admins can generate a Vault Configuration Report that includes all objects in your Vault.