Risk Management
Unified management of RMPs
Risk Management Plans and associated documents need to be created and distributed to Affiliates and Distributors. Traditionally those tools involve external systems for sharing content and a separate system for registering and reporting on implementation status. This can all be done in a unified and traceable way in the CARA Life Sciences Platform, with Affiliates / Distributors logging in to a simple UI to perform their tasks.
With the CARA Life Sciences Platform, you manage the end-to-end process in a single, unified cloud platform, eliminating the need for Excel trackers and networks of siloed point solutions.
Benefits
Distribution
Trigger workflows for distribution of RMPs and associated documents to affiliates and distributors – manually, or automatically via an API call from an external system.
Documentation
Manage the creation, review and approval internally of Risk Management Plans and tools and provide the documentation required for Regulatory Submissions.
Portal Access
Distributors, affiliates and other third parties can access CARA via a simple portal to acknowledge, submit and confirm required actions with Agencies.
Tracking
Central regulatory affairs has a real-time view per-product and per-country of the status of RMPs and associated documentation and activities, and can track all these in the CARA RIM module.
Metrics & Analytics
CARA provides an extensive dashboard and analytics capability, which allows reporting on the status of Risk Management and Plan implementations globally.
Distribution
Documentation
Trigger workflows for distribution of RMPs and associated documents to affiliates and distributors – manually, or automatically via an API call from an external system.
Manage the creation, review and approval internally of Risk Management Plans and tools and provide the documentation required for Regulatory Submissions.
Portal Access
Tracking
Distributors, affiliates and other third parties can access CARA via a simple portal to acknowledge, submit and confirm required actions with Agencies.
Central regulatory affairs has a real-time view per-product and per-country of the status of RMPs and associated documentation and activities, and can track all these in the CARA RIM module.
Metrics & Analytics
CARA provides an extensive dashboard and analytics capability, which allows reporting on the status of Risk Management and Plan implementations globally.
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