Veeva RIM Active Dossier Features 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.

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  View the current, submitted, and superseded documents side-by-side by country in a single view.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

Veeva RIM

Active Dossier is part of Veeva RIM, which streamlines global regulatory processes on a single, cloud-based platform. This enables medtech companies to:

• Ensure teams are developing reliable regulatory content with high data integrity
• Coordinate regulatory efforts across headquarters, affiliates, and partners
• Respond faster to changing regulations
• Increase end-to-end process efficiency from submission planning to publishing