Rimsys Features

Document Management (4)

Dossier Management: Tracks submissions plans for products to report against milestones and progress. Streamlines the entire dossier lifecycle and tracks the status of all submissions.
Tech Files: Supports the creation of technical files and essential principles checklists.
Submission Planning: Provides templates and tools to create all planned regulatory content for a product.
Archiving: Stores all previously submitted documents for use in audits or future submissions.

Audit Trails: Enables traceability into the entire pre- and post-market lifecycle to monitor milestones, time to completion, and updates and approvals.
Label Management: Prepares and submits labels and UDI submissions for products, validated accordingly to regional regulatory requirements.
Live Dashboards: Maintains up-to-date dashboards for overseeing every task, deadline, project status, and workflow.
Collaborative Authoring: Allows multiple users to collaborate on documents and flag errors or updates.
Product Information: Centralizes and tracks detailed product information, such as registration status and selling status for each location and market.

Automated Notifications: Tracks key deadlines for submissions, renewals, and audits, and streamlines the document retrieval process for each activity.
Post-Market Surveillance: Streamlines post-market product data collection and analysis for safety, sentiment, and future product improvements.
Communication Tools: Fields internal team and external agency messages or tickets related to regulatory concerns, and inboxes all correspondences.
Regulatory Intelligence: Connects to regulatory databases and market sources to monitor upcoming changes that may impact product selling status.