FCPA compliance for a large medical devices company
One of the largest multi-national medical device manufacturers, uses Be Informed to solve regulatory compliance issues requiring multi-language global collaboration, review and publication of legal documents.
The Company selected Be Informed to solve their Foreign Corrupt Practices Act (FCPA) compliance issues. FCPA is a complex multi-jurisdiction, multi-language policy problem. The FCPA is a federal law enacted in 1977 to prohibit companies from paying bribes to foreign government officials and political figures for the purpose of obtaining business. Enforcement of the regulation has increased dramatically in the past three years. Under the law, it is necessary to demonstrate due diligence.
The Company contracts with more than 3,000 partners in 120 countries and 14 languages. Prior to Be Informed, updating due diligence instruments required a large team of people 2 years, impacting both compliance and business development. Activities included soliciting required changes from internal and external sources, consolidating changes for legal review, reviewing changes made by corporate with various business units, approving, and translating back to the 14 different languages. Not only was the process lengthy, it was labor intensive and error prone. This prevented the company from being proactive and complicated business development. Further, getting access to critical personnel necessary required to create and review materials, slowed down project execution. Costs to change the instruments and proliferation of different versions resulted in budget overruns and project delays.
The Company successfully replaced the entire workflow with constraint based dynamic workflows that allow processes to be performed in hours and days. Eliminating administrative tracking and coordination activities, automatically detecting and notifying where review or translation are required and guaranteeing complete auditability of the process contributed to increased accuracy, confidence and business agility. Efficiencies were derived from the ability to eliminate multiple phases of review, automatically notifying team members of pending activities and escalating as necessary to ensure processes don’t get slowed down. Users were also able to track review activities and pick up where they left off greatly simplifying the review and update cycles.
All workflows are managed through a central dashboard to allow monitoring and reporting of process activity and overall progress toward completion as well as provide expediting and work request escalation.
The impact on the program has been significant, allowing the customer to expand their due diligence activities and enhance their ability to respond to regulatory challenges. During the second phase of the project, The Company will integrate contract renewals with the due diligence process ensuring that due diligence has been performed prior to contracts being let. The customer intends to use the same functionality to address other global regulatory problems including internal ethics and compliance review, annual report creation and many medical industry specific quality initiatives where translation to multiple languages is required.