Veeva RegulatoryOne Regulatory Documents is a complimentary application available to customers with either RegulatoryOne Compliance Management or RegulatoryOne Registration & Dossier Management Vaults that helps users manage regulatory documents, allows seamless collaboration, reduces compliance risk, and improves regulatory processes. Regulatory Documents. Regulatory Documents provides a standardized data model, allowing users to manage documents in relation to relevant products, formulas, and studies, and includes pre-defined document types such as Raw Material Questionnaire (RMQ), Regulatory Data Sheet (RDS), Safety Data Sheet (SDS), and Technical Data Sheet (TDS). Regulatory Affairs users can capture studies and study results in a single place, allowing them to reference those results to determine if a formulation’s composition is compliant and safe to use in specific locations.
Regulatory Documents is part of the Veeva RegulatoryOne family of applications. Within a single Vault, your organization can have one (1), two (2), or all of these applications.
Features
RegulatoryOne Regulatory Documents is built on Veeva Vault and includes the features described in Veeva Vault Help for Platform. In addition, it provides the following feature:
- Export Binder as Merged PDF: Regulatory Documents provides users with the ability to export all document renditions in a binder as a single PDF, allowing Regulatory teams to easily generate a single file to send to authorities when registering new products and to customers in response to regulatory requests.
Related Articles
Learn more about using the Regulatory Documents application in these articles:
Admin Articles
Learn about configuring the Regulatory Documents application in these articles: