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Beyond PI in Pharma: Modern Industrial Analytics & CFR Part 11 Compliance

Join dataPARC and Catalyx as they explore today’s industrial analytics options and show how modern, historian-agnostic solutions can provide real-time insight, 21 CFR Part 11–ready data integrity and auditability, and faster quality decisions—all without disrupting production.

June 12, 2025

2:00 PM ET / 1:00 PM CT / 11:00 AM PT / 7:00 PM GMT

Duration: 1 hour

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Summary 

In an industry where regulatory rigor, batch quality, and time-to-market define success, pharmaceutical manufacturers still often rely on decades-old process-information tools—including long-trusted systems such as the AVEVA PI System—even as the analytics landscape has evolved. Join dataPARC and Catalyx as they explore today’s industrial analytics options and show how modern, historian-agnostic solutions can provide real-time insight, 21 CFR Part 11–ready data integrity and auditability, and faster quality decisions—all without disrupting production.

We’ll cover how to:

  • Map the current industrial analytics landscape – A straightforward framework for comparing historians, visualization layers, and advanced analytics offerings.
  • Understand the role of AI / machine learning – Practical, low-hype examples of where emerging tools add value in batch and utilities monitoring.
  • Consider the options – An evaluation of the considerations when evaluating your system options, including migration from AVEVA PI
  • Plan a low-risk migration path – When migrating from AVEVA PI, proven methods for converting legacy displays, calculations, and data sets while preserving fidelity and minimizing downtime.
  • Ensure 21 CFR Part 11 compliance – Important topics for seamless validation in GMP environments.

Speakers

Kevin Jones

Director of Partner & Product Strategy 

dataPARC

Kevin Jones has nearly 25 years of experience in delivering decision support and data analysis systems to industries including Oil and Gas, Paper, Mining, Energy & Utilities, and Chemical Manufacturing. Currently the Director of Partner & Product Strategy at dataPARC, Kevin has a diverse background ranging from engineering, product management to sales management.

He has a track record of growing business globally, and a deep understanding of IIOT and ISA95 principles. Outside of work, Kevin is a proud husband and father to two energetic boys. He holds a BS in Chemical Engineering from the University of Idaho.

Savannah Schmidt

Lead Engineer

Catalyx

Savannah Schmidt is a Lead Engineer at Catalyx in the Process Control & Automation division. She specializes in implementing and administrating data historian solutions with clients in the pharmaceutical and biotech industries. She has experience with ensuring GMP compliance for historian solutions and has a Bachelor’s degree in Chemical Engineering

Adam Cooper

Senior Sales Engineer

dataPARC

Adam Cooper has spent over 15 years at dataPARC, moving from a Process Engineer role to his current position as Senior Sales Engineer. During this time, he's managed projects for clients in the US, China, Taiwan, and Indonesia. His work involves project management, system implementation, and training on dataPARC applications.

Adam also collaborates with the sales and development teams to scope new projects and implement new features. He holds dual BS degrees from the University of Washington in Paper Science and Engineering, and Chemical Engineering.

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