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.
Product Management (5)
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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.
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Product Information
Centralizes and tracks detailed product information, such as registration status and selling status for each location and market.
Regulatory Affairs (4)
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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.
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Regulatory Intelligence
Connects to regulatory databases and market sources to monitor upcoming changes that may impact product selling status.
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