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National Payor
Regulatory Compliance

Client Situation

The client was looking for an enterprise workflow/process management system to automate their entire Regulatory Affair (RA) department. They wanted a system that would have the ability to collaborate and track various regulatory processes including filings, product development, audits, tracking of complaints, ethics hotline, etc and provide reports on the data across multiple areas of the system.

There was no formal integrated system available for the entire RA department. Business units were using local databases or spreadsheets to support individual processes. This problem presented the client with the need to implement an enterprise compliance management system to mange these processes and render meaningful data/reports for the entire department.

Approach

• Azilon provided a phased implementation approach under a single enterprise web based compliance platform starting with the Filing and Product development automation. Additional process automation solutions were built on the same platform.
• The platform provided common compliance built-in features including centralized organization structure, user management, workflow, alerts, email integration, document repository, calendar that were shared between various systems.
• The solution also provided integration with the clients marketing department for automation of the advertisement piece filing with CMS.
• The solution provided a dynamic form builder allowing the RA department to the design custom filing forms as per the agency requirements.