Manageable regulatory compliance

Guarantee compliance for a medical device manufacturer

An USA based large and leading multi-national medical device manufacturer contracts with more than 3000 partners in 120 countries and 14 languages. The Foreign Corrupt Practices Act (FCPA) requires multi-language global collaboration and review and publication of legal documents. FCPA is a complex multi-jurisdiction, multi-language policy problem. The medical device manufacturer needed a digital process to support and to guarantee regulatory compliance (demonstrable due diligence) for FCPA.

Constraints based process

CognitionConcept defined an architecture that combines components for dynamic case management and complex decision making based on semantic technology. Together with the customer CognitionConcept successfully replaced the entire workflow for regulatory compliance with a constraint based dynamic process that allows the process to be performed in hours and days instead of months. 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 by maintaining the context of changes to questions and questionnaires, including that context throughout the process, 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.

Business prototyping

For most people administrative processes are very abstract and regulatory compliance is even more abstract. The reference of the users was their current process implementation and their annoyances about it. But off course it was not the intention to build an improved legacy system. To support a new business model and to optimally use new features, users have to experience the new possibilities. Therefor CognitionConcept made prototypes in order to enable the users to think about their future mode of operation where after they were able to experiment with it bearing in mind a business operating model for the coming years.

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.