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.

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.

Key Shared Objects

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.
  • 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.