2023 ISPE Europe Annual Meeting

17 May 2023

Last week, I had the opportunity to present “Digital Transformation: Unified Namespace Deployment to a Pharmaceutical Environment” with a client in the Pharma 4.0 track at the 2023 ISPE Europe Annual Meeting in Amsterdam.

Unified namespace, or UNS, coined by Walter Reynolds, is a concept that allows real-time processing and traffic of contextualized, normalized, and aggregated information [1]. The topic sparked subsequent multiple discussions with the panel and clients regarding the modifications they would need to make to their products and devices to integrate with UNS.

During the regulatory discussions, the regulators emphasized the importance of data handling and the need for trusted data to make informed decisions and derive value. I came across an interesting US Food and Drug Administration (FDA) concept called Quality Management Maturity (QMM), which will be voluntary for end-user clients. This approach utilizes outputs as leading indicators of quality at client sites, potentially reducing the sense of panic that arises when FDA site visits are announced.

Reflecting on the ISPE Europe Conference, I feel my Arcadis DPS Group automation colleagues are on the right track with our engineering design efforts. Unless the clients specifically instruct otherwise, we should approach all intelligent devices and systems as connected. These systems should be viewed as “Peninsulas of Automation” rather than “Islands of Automation.” It was a great experience, and I look forward to more engagement with my peers on this topic.