RegulatoryOne Registration & Dossier Management Overview

Vault RegulatoryOne Registration & Dossier Management is an application that helps users manage registrations and dossiers from end to end in regulated markets. Regulatory Affairs users can initiate a regulatory process with transparency, identify and assess requirements with accuracy, collaborate on executing those requirements with efficiency, and monitor registrations to ensure traceability.

Registration & Dossier Management is part of the Vault RegulatoryOne family of applications. With a single Vault, your organization can have one (1), two (2), or all of these applications.

Features

RegulatoryOne Registration & Dossier Management is built on Vault and includes the features described in Vault Help for Platform. In addition, it provides the following features:

  • Split registration items: Registration & Dossier Management provides users with the ability to quickly create new related registration items in bulk based on Admin-defined split rules applied to a source registration item. This allows your organization to create and manage granular registration items that may need to be assessed in different ways. Admins can also configure a viewer to display related registration items in a hierarchical structure.
  • Conduct global change impact assessments: Registration & Dossier Management provides users with the ability to identify registration items potentially impacted by a global operational change and create new registration items copied from the impacted items with user-specified values that reflect the change.
  • Conduct local impact assessments: Registration & Dossier Management provides users with the ability to assess if a registration item’s objective can be accomplished by amending an existing registration or if a new registration is required for a location’s specific regulations, allowing them to begin the appropriate registration process.
  • Populate registrations: Registration & Dossier Management provides users with the ability to populate certain fields on registrations and registration objectives with values propagated from related registration items based on Admin-defined mappings.
  • Manage requirements: Registration & Dossier Management provides users with the ability to define and track what needs to be completed for a requirement. For each registration objective and registration item, users can generate a dynamic set of Admin-defined requirements and expected document lists or generate Requirements based on an existing dossier and reuse shared requirements. Users can review the requirements in a hierarchical structure using the Requirement Hierarchy Viewer, then adjust records, nested order, and matched documents in the viewer before generating Dossier Binders.
  • Create dossier documents from templates: Registration & Dossier Management provides users with the ability to automatically create multiple documents for a dossier from Admin-defined templates.
  • Create Dossier Binders: Registration & Dossier Management provides users with the ability to create Dossier Binders that reflect the requirement hierarchy and includes all expected documents for each requirement.

Data Model

Registration & Dossier Management 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 Registration & Dossier Management 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.

Key Objects

In addition to the shared RegulatoryOne data model, the Registration & Dossier Management application has additional objects to house data. This is a list of core Registration & Dossier Management objects, but it does not include all objects:

  • Event: This object represents a planned occasion that may need regulatory-related activities to be completed before it takes place.
  • Location: This object represents the location where a product must be registered.
  • Registration: This object represents proof that validates clearance in a state, country, region, and by Third-Party Certification or Retailer.
    • Registration Objective: This Registration object type represents a snapshot of a registration and the related Registration Items at a specific point in time.
  • Registration Item: This object represents a request to identify or scope out what needs to be done to market or sell a product in a jurisdiction.
    • Non-Registration Dossier: This Registration Item object type represents a dossier not typically meant for submission to authorities.
    • Product Registration Item: This Registration Item object type represents a dossier intended for submission to register a product.
  • Requirement Library: This object represents a regulatory activity that needs to be completed or artifacts that need to be collected in order to support registration processes.
  • Requirement: This object represents a Requirement Library specific to getting a Registration Item completed.
  • Regulatory Request: This object represents a request for information from an authority during the registration process.

Learn more about using the RegulatoryOne Registration & Dossier Management application in these articles:

Admin Articles

Learn about configuring the Registration & Dossier Management application in these articles: