Veeva 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 Veeva 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 Veeva Vault and includes the features described in Veeva 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.

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

Admin Articles

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