lsafety

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.

Latest Resources

Case Study

Pfizer Case Study

Learn how CARA enabled a global Pharmaceutical company to move away from legacy systems and improve user experience.

Read More »

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