Automate Regulatory Report Creation Process

Client

 A $40+ Billion biopharmaceutical company that discovers, develops, manufactures, and sells healthcare products worldwide.

Project Goals

The company desired a faster and more efficient method to produce and deliver over 200 regulatory reports required annually by regulators

• Eliminate paper-based reports, some of which had over 10,000 pages
• Ensure reports were submitted within regulatory time limits
• Allow for increase emphasis on report content versus physical report generation

Deliverables

The project delivered:

• A database, Electronic Document Management System (EDMS), and workflow based application that supported the creation and delivery of global regulatory reports in both electronic and paper formats
• Process and information technology training

Results

• Company was able to centralize regulatory reporting across the globe
• Cost reductions associated with scanning, printing, and shipping paper reports
• Improved compliance due to reduced generation times and improved management reporting