Next Generation RIM
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Veeva Vault RIM – Planned for Availability Q1 2016
A global authoritative source for all regulatory content and product registration data.
Veeva Vault RIM is a suite of applications providing fully integrated regulatory information management (RIM) capabilities on a single cloud-based platform including submission document management, submission archiving, health authority correspondence and commitments, and product registration management.
The visibility that results from a unified solution will streamline global processes, helping life sciences companies respond faster to business changes, compliance concerns, and health authority requests.
BENEFITS
- Always current: Veeva adds new functionality three times a year to keep you current with technology and emerging regulatory requirements. You can concentrate on your business, rather than system upgrades and custom IT development.
- High productivity: The Vault cloud platform delivers fast performance to your users all around the world. Powerful search and consumer web ease-of-use lower training requirements and result in higher and more frequent use of the system.
- Reliable data quality: Capture timely, accurate information directly from each region and share it globally to eliminate data duplication and discrepancies.
- Agile and integrated: Leverage Vault’s powerful platform capabilities to quickly configure new data types and workflows, integrate with other regulatory systems, and quickly write the reports you need to keep processes moving.
Applications
Vault Registrations – Planned for Availability Q1 2016
Veeva Vault Registrations provides a single, comprehensive solution to manage product registration data worldwide, including registration status, variations, and health authority interactions.
Vault Registrations allows companies to manage registration information such as approved pack sizes, dosage forms, and strengths across all global markets. As a shared resource for headquarters and affiliates, Vault Registrations helps globalize key processes and improve data quality.
Vault Registrations also provides IDMP support. The application can receive data from external systems and will generate IDMP messages for the European Medicines Agency based on scope and timelines defined by the implementation working group. Vault Registration’s flexible data model natively maps to the ISO IDMP standard and will be adjusted quickly to incorporate future IDMP updates as they are released.
Vault Submissions – Available Today
Veeva Vault Submissions manages the authoring, planning, collection, and approval of documents for submission to regulatory authorities.
Vault supports and extends the DIA Reference Model to ensure that the content taxonomy aligns with industry norms and facilitates collaboration with external parties. Submission templates automatically generate a “bill of materials” that lists required documents, so it’s instantly clear what’s missing. Then, document templates and placeholders assist with the creation and collection of required materials, while Vault’s reporting and approval workflows ensure necessary documents are included and complete.
Vault SubmissionsArchive – Planned for Availability Q1 2016
Veeva Vault SubmissionsArchive 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.
Vault SubmissionsArchive will allow you to import submissions directly from file shares while preserving the eCTD XML backbone, folder structure, and inter-document hyperlinks. Users can navigate documents exactly as they were submitted to regulatory agencies and directly from the repository without needing to download files. An integrated eCTD viewer provides current, sequential, cumulative, and regulatory action views so users can quickly navigate published dossiers.
