Navigating the Regulatory and Distribution Compliance landscapes can be daunting, especially when each country has its unique requirements. At Edwards Lifesciences, we understand the challenges of managing the complexity of these requirements.

Edwards Product Attribute Controls (ePAC) is the system where model creation and revision are maintained.  ePAC defines, controls, and establishes the relationship of attributes related to the distribution control of Edwards' products.  Part attributes, country requirements, and regulatory compliance data determine which product configuration(s) are compliant for distribution in the Country of Sale.

This presentation will show how the Aras platform is used to control distribution while adhering to Regulatory and Distribution requirements.  We will go over the processes established to capture regulatory requirements and how the system analyzes data to ensure compliant distribution.