Vault 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 Vault RegulatoryOne family of applications. Within a single Vault, your organization can have one (1), two (2), or all of these applications.
RegulatoryOne Regulatory Documents is built on Vault and includes the features described in 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.
Regulatory Documents shares some common data model components with other RegulatoryOne applications, which allows you to consolidate data for all of these applications in a single Vault. This is not a complete list of all Regulatory Documents objects but provides some explanation of important core objects in the data model.
Depending on your Vault’s configuration, object labels may appear differently than the labels mentioned in this article.
In addition to the shared RegulatoryOne data model, the Regulatory Documents application has additional objects to house data. This is a list of core Regulatory Documents objects, but it does not include all objects:
- Regulatory Study: This object represents a study and contains information about study type, endpoint, method, and subtype.
- Regulatory Study Formulation Join: This object joins the Regulatory Study and Formulation objects, and represents a study’s formulation.
Learn more about using the Regulatory Documents application in these articles:
Learn about configuring the Regulatory Documents application in these articles: