Active Dossier Feature Brief

Increase document visibility throughout the RIM lifecycle

Active Dossier is a list of a sponsor’s current and submitted documents across all products and markets. The Veeva RIM platform automates the generation and calculation of dossier records based on related submission data. Active Dossier then organizes linked documents into a multi-market document view based on data from the submissions process. This provides comprehensive oversight of the entire lifecycle of dossiers for regulatory authors, stakeholders, and managers in the end-to-end platform.

Benefits

• Visibility

  Gain a holistic view of documents throughout the RIM lifecycle.

• Focus

  Expedite identification of documents that require updates.

• Single view

  Connect and aggregate data between different submissions and archived data to provide more document context.

Features

View documents in multiple markets

• View the current, submitted, and superseded documents side-by-side by country in a single view.

• Filter and save dossier views based on product family, market, or region for quick access to relevant documents in a dossier.

Link to related documents and data

• Reference additional information on each document in the dossier, including the source document, submitted document, and translated document.

• Establish traceability by linking documents to related regulatory records, such as applications and submissions.

Integrate with other submission activities

• Automate generation of the dossier based on the existing regulatory submission process within the Veeva RIM platform.

• Maintain a calculated dossier lifecycle status based on the existing regulatory submission process in Veeva RIM.

Learn more about how Veeva Submissions can streamline your global regulatory submission process.