It unifies regulatory systems and processes, improving visibility, data quality, and operational agility.

Key Features

• End-to-End Regulatory Management:
  • Vault Registrations: Manages product registration data worldwide, including registration status, variations, and health authority interactions. It supports IDMP data points and evolving regulatory standards.
  • Vault Submissions: Streamlines submission planning through approval by automating regulatory process steps. Users can create submission content plans, render submission-ready documents, and track submission status with complete traceability.
  • Vault Submissions Publishing: Incorporates publishing functionality for end-to-end submission development, using a continuous publishing process to create, validate, and submit dossiers.
  • Vault Submissions Archive: Stores a complete history of regulatory submissions securely in the cloud, allowing affiliates to download and reuse submissions or components for local markets.
• Unified and Connected Platform:
  • Vault Connections: Seamlessly transfers data and documents between Vaults, enabling automatic sharing of product, study, and site information. Integrates with other Veeva Vault applications to streamline cross-functional business processes.
• Improved Compliance and Data Quality:
  • Regulatory Compliance: Ensures teams develop reliable regulatory content with high data integrity, supporting compliance with global regulations.
  • Audit Trails and Version Control: Maintains detailed audit trails and version control for all regulatory documents, ensuring transparency and accuracy.
• Enhanced Visibility and Efficiency:
  • Real-Time Dashboards: Provides real-time visibility into global submission status, operational progress, and key metrics through comprehensive dashboards and reports.
  • Automated Alerts: Sends automated alerts for changes in study data and milestones, prompting necessary actions to maintain compliance and efficiency.

Benefits

• Speed to Market: Responds faster to changing regulations and increases process efficiency from submission planning to publishing.
• Stronger Compliance: Ensures high data integrity and reliable regulatory content, reducing the risk of non-compliance.
• Global Alignment: Coordinates regulatory efforts across headquarters, affiliates, and partners within a single RIM system.
• Operational Agility: Streamlines end-to-end regulatory processes, enabling organizations to respond quickly to product changes and compliance concerns.