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.
Related Articles
Learn more about using the Registration & Dossier Management application in these articles:
- Splitting Registration Items
- Conducting Global Change Impact Assessments
- Conducting Local Impact Assessments
- Populating Registration Fields
- Generating Requirements
- Creating Dossier Documents from Templates Automatically
- Using the Requirement Hierarchy Viewer
- Working with Dossier Binders
Admin Articles
Learn about configuring the Registration & Dossier Management application in these articles:
- Configuring Split Registration Items
- Configuring Global Change Impact Assessments
- Configuring Local Impact Assessments
- Configuring Registration Field Population
- Configuring Requirement Generation
- Configuring Automatic Dossier Document Creation from Templates
- Configuring the Requirement Hierarchy Viewer
- Configuring Dossier Binders
- About RegulatoryOne Component Types