Vault RIM Basics: Submissions is a preconfigured system that allows your organization to plan, author, review, approve, and assemble regulatory submission documents, such as clinical study reports, manufacturing information, nonclinical reports, and labeling.
Vault RIM Basics: Submissions Archive is an optional add-on that allows you to view and import published submissions and health authority correspondence.
Vault RIM Basics Features
The following core functionality is available in Vault RIM Basics Submissions and Submissions Archive:
- Core Data: Allows you to manage core data for applications, submissions, products, clinical studies, and nonclinical studies.
- Document Management: Allows you to manage regulatory documents, including standard reference models, workflows, and life cycles.
- Document Control: Provides consolidated document authoring and review workflows, and document approval workflows with and without eSignature.
- Submission Content Plans: Allows you to use predefined content plans for managing progress while authoring eCTD (Electronic Common Technical Document) submissions.
- Correspondence: Allows you to manage official correspondence documents to and from health authorities.
- Controlled Document Templates: Allows you to create, approve, and use document templates.
- Dashboards: Includes predefined role-specific dashboards.
- Collaborative Authoring: Allows real-time collaborative authoring in Microsoft 365.
- Vault Clinical Connection: Connects with Vault Clinical (requires Vault Clinical).
- Archive Viewer: Allows you to import and view published submissions.
- Vault Mobile: Allows you to access and perform key functionality with the Vault Mobile application.
- Single Sign-on (SSO): When configured, allows access to the above functionality using SSO.