Veeva Submissions is a core application within the Veeva Vault Regulatory Information Management (RIM) suite, providing an end-to-end solution for managing the entire lifecycle of regulatory submissions content in the life sciences industry. Built on the secure, cloud-based Veeva Vault Platform, it serves as a single, authoritative source for all regulatory documents and data, eliminating the need for fragmented, siloed tracking systems like spreadsheets.
Key Capabilities and Benefits:
Veeva Submissions streamlines the complex process of regulatory content management from planning through publishing. It is designed to manage the authoring, review, approval, and assembly of critical submission content, such as clinical study reports, manufacturing information, nonclinical reports, summaries, and labeling.
- Content Planning & Assembly: Users can create submission outlines using pre-configured templates based on industry standards like the eCTD (electronic Common Technical Document) and the DIA EDM Reference Model. This capability moves content planning away from spreadsheets and automates the matching of documents to the submission structure.
- Collaboration and Control: The system provides full enterprise content management features, including version control, approval workflows, and real-time co-authoring capabilities (e.g., with Microsoft Office™). This enables global teams and affiliates to securely access and contribute to documents from any location.
- Compliance and Visibility: It includes automated validation and compliance checks and provides real-time status reporting and dashboards. This visibility helps submission managers track the progress of every document, mitigating risks to submission timelines and ensuring submission readiness.
- Unified RIM: As part of the Veeva RIM family, it shares a common data model with other Veeva Vault applications (like Registrations and Submissions Publishing), ensuring seamless data flow and content reuse across the organization.