MAR-APR 2019

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16 INTECH MARCH/APRIL 2019 WWW.ISA.ORG Empowering an effective PAT methodology Operationalizing advanced analytics for data-driven decision making By Lisa Graham, PhD, PE L everaging process analytical technology (PAT) advancements helps companies derive value by combining data from process and analytical instruments with advanced analytics to: l empower subject-matter experts (SMEs) l augment process development and scale up l optimize the globally connected system l realize the potential of the Industrial Internet of Things (IIoT/Pharma 4.0) l reduce manufacturing cycle time The concept of PAT has grown into a broad field encompassing process analysis, chemical engineering, chemometrics, modeling, process automation and control, and knowledge and risk management. This approach is consistent with the FDA's document titled Guidance for Indus- try PAT, which is "written for a broad industry audience in different organizational units and scientific disciplines" and "discusses princi - ples with the goal of highlighting opportuni- ties and developing regulatory processes that encourage innovation." From an innovation perspective, a strong PAT methodology includes a plan for connec - tion to disparate data sets, advanced analytics, and the culture change required to actively im - plement insights through improved workflows. This is important, because PAT should ulti - mately support data-driven decision making, which requires a firm grasp of measurements, data science, and analytics workflows—along with a plan for summarizing and disseminat - ing the knowledge gained (figure 1). Further, the value of the outcome should demonstrate a return on investment whether the analyses are using an effective PAT methodology for diag - nostic, predictive, monitoring, prescriptive, or descriptive views (figure 2). FAST FORWARD l Reasons to implement PAT include reduced cost, improved reliability, and better quality. l Leading challenges are changing company culture and accessing and analyzing data. l Two case studies show the results of applying advanced analytics to PAT projects.

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