A New Challenge For Quality Experts – The Data Quality Concept

The role of quality systems in pharmaceutical organizations has grown faster than any other function during the last 15 years. During this period, a small group dedicated to traditional Compliance grew and expanded to include Quality Experts in areas such as validation, product release, operations, sterility assurance, and other specialized functions. Creating a deeper quality connection between manufacturing and engineering has always been the aim of that growth. Little by little, quality became fundamental to every step of the pharmaceutical manufacturing process: changing from a silo concept to a more fluid one. Now, a new challenge is approaching. The fourth industrial revolution (Pharma 4.0™1) is the beginning of the “Smart Facility” era, where digitalization and automation will combine to reach very complex applications and life cycles. In this brand-new framework, Quality Experts will face the challenge of rethinking their roles and redesigning the Quality Systems of their pharmaceutical companies to be based on the concepts of Data Quality.