Vault 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 Vault and includes the Platform features described in 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. Admins can generate a Vault Configuration Report to see all objects in your Vault.
Depending on your Vault’s configuration, object labels may appear differently than the labels mentioned in this article.
This is not a complete list of all RegulatoryOne objects but provides some explanation of some important shared objects in the data model.
- Product: This object represents a product and contains information about the type of product, version information for the product, and a reference to the Formulation object.
- Product Composition: This object is a many-to-many self-reference to Product and represents the composition that makes up a product.
- Formulation: This object represents a formulation and contains information about version, classification (raw material, formulation, or substance), and supplier.
- Formulation Composition: This object is a many-to-many self-reference to Formulation and represents the composition that makes up a formula.
- Packaging: This object represents packaging and contains information about version information for the packaging.
- Packaging Composition: This object is a many-to-many self-reference to Packaging and represents the composition that makes up a package.
- Product Packaging: This object joins the Product and Packaging objects and represents a product’s packaging.
- Organization: This object represents an external organization and contains information about organization type, address, location, and contact details.
- Organization Person: This object joins the Organization and Person objects and represents a person associated with a particular organization.
- Location: This object represents the location of a product’s target market and contains information about the type of location.