Vault RIM Suite
A global authoritative source for all regulatory content and product registration data.
The Vault RIM Suite provides fully integrated regulatory information management (RIM) capabilities on a single cloud-based platform including submission document management, product registration management, health authority correspondence and commitments, submission archiving, and comes with fully integrated IDMP capabilities.
The visibility that results from a unified solution will streamline global processes and improve data quality, helping life sciences companies respond faster to business changes, and health authority requests.
- Speed to market globally – Respond faster to compliance issues and business changes.
- Stronger compliance – Achieve reliable content and data quality.
- Global alignment – Gain visibility across HQ, affiliate, and partner activities.
- Unified and connected: A unified suite within Veeva Vault Development Cloud, streamlining cross-functional business processes with a single cloud platform.
Veeva Vault Registrations provides a single, comprehensive solution to manage product registration data worldwide, including registration status, variations, and health authority interactions. Vault Registration’s flexible data model natively maps to the ISO IDMP standard and will be adjusted quickly to incorporate future IDMP updates and message generation capabilities.
Veeva Vault Submissions manages planning through approval of all submission documents. Manual steps are automated throughout the process, from creating submission content plans, to rendering submission-ready documents, and tracking their status. Relationships between correspondence, commitments, submission records, and source documents, provide complete traceability for your regulatory activities.
Veeva Vault Submissions Publishing incorporates publishing functionality within the Vault RIM Suite to provide end-to-end submission development on a single platform. Employing a continuous publishing process to create, validate, and submit dossiers will dramatically speed your submission delivery. Planned for availability in early 2018.
Veeva Vault Submissions Archive will store your complete history of regulatory submissions securely in the cloud. A high-performance cloud architecture makes access to published submissions fast and easy for authorized users. Affiliates can download submissions or submission components for reuse in local markets and upload their submissions to local health authorities.
A Single, Authoritative Source for RIM Globally
The Hidden Upside of IDMP