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.
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 RIM Basics: Submissions and RIM Basics: 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 & Commitments: Allows you to manage official correspondence documents to and from health authorities and track regulatory commitments.
- Controlled Document Templates: Allows you to create, approve, and use document templates.
- Reports and Dashboards: Includes predefined role-specific reports and 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.