source:veeva

Vault Registrations:

Centralizes global product registration planning, tracking, and reporting.Manages marketing and investigational registration information, including updates.Facilitates quick assessment of manufacturing or label changes, aiding informed decisions.Adaptable data model ensures compliance with global regulations like XEVMPD and IDMP.

Vault Submissions Publishing:

Integrates with Vault RIM for accelerated submission delivery.Enables cross-document hyperlinking and validation early in the process.Streamlines end-to-end publishing process for greater automation, transparency, and speed.

Vault Submissions:

Provides a single, secure cloud platform for managing regulatory submissions content.Covers the entire submission lifecycle from planning to authoring to assembly.Allows secure access and contribution to documents from any location, device, or time.Facilitates cross-linking to source materials and visual reminders of outstanding tasks.Maintains a single source of truth while allowing each department to manage content within their context

Vault Submissions Archive:

Stores eCTD and non-eCTD electronic submissions with links to related health authority correspondence.Facilitates download and reuse of submissions or submission components by affiliates.Allows import of submissions directly from file shares while preserving structure and hyperlinks.Integrated eCTD viewer provides comprehensive views of submission lifecycle for quick reference.

Conclusion:

Veeva Vault RIM Suite revolutionizes regulatory operations by offering comprehensive solutions for registration management, submissions publishing, submissions management, and archive storage. With its seamless integration and user-friendly features, it empowers life sciences companies to navigate regulatory complexities efficiently and stay ahead in today’s competitive landscape.