Manufacturers today spend considerable time and effort ensuring that their products comply with a multitude of regulatory mandates. Yet many companies’ approaches to ensuring compliance have left them at a high risk of noncompliance, potentially resulting in an inability to sell in global markets, unmet customer mandates, blocked shipments, and associated revenue loss. This high risk level exists despite significant efforts to achieve compliance by most companies. In fact, meeting compliance challenges today has resulted in increased product development cost, decreased ability to innovate, and added staffing.