This year’s ISPE Annual Meeting and Expo in Orlando highlighted a number of key topics and trends in our industry’s digitization journey. These covered everything from industry progress with manufacturing and laboratory automation and digitization to trends in new technologies like blockchain and ways to modernize quality organization and systems to be digital future ready.

The intertwining of topics at the conference clearly highlighted that a successful digitization journey requires not just a technology focus, but also a multi-dimensional focus on modernizing the quality system and the role of quality. Key challenges facing the Quality organizations include redefining how to maintain compliance and quality amidst an explosion in digital information, the maturing of new data technologies such as artificial intelligence and blockchain, the expanding quantities of digital data and external partners in the supply chain, the increasing speed of new product introductions, and the rapidly evolving expectations to have a holistic governance program to manage data integrity risk and build data integrity by design.

To achieve this transformation, quality organizations must focus on keeping pace with investments in digitization and technology by overhauling and modernizing their quality systems and processes to leverage new data sciences and the expanding quantities of process data, to design data integrity into all elements of the quality system, to build the organizational capabilities necessary to exploit new technologies and to manage new supply chain partners, and to foster an organization wide culture of data ownership, awareness and curiosity. Quality’s mission can no longer be effectively achieved via the traditional and often manual methods of assuring compliance and quality. Change is paramount to achieve new paradigms in quality assurance and operations and to be successful, Quality must be a continuous and present partner in the company’s digitization journey.