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Tracy Hibbs

Tracy has worked for Waters Corporation since 1999 and has held a variety of positions including Technical Trainer, Business Impact Consultant, Training Manager for Informatics and Data Integrity, Principal Consulting Marketing Manager, and currently, Director of Regulatory and Compliance Strategy for Informatics solutions. Tracy provides support for Waters Informatics solutions and is concentrated on helping organizations achieve quality management maturity. Prior to joining Waters, Tracy was a Research Scientist where she gained experience in chromatography and the associated data systems.

Posts From Tracy Hibbs

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AI Maturity in GMP: Accelerating Your Digital Journey at Warp Speed, Safely
July 14, 2026|
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Most AI projects fail. The organizations that succeed are the ones that build governance before they build velocity. Written by Tracy Hibbs and Tony Sacchetti, Waters Corporation Artificial intelligence (AI) is poised to take routine work and shift it to fully automated workflows. Currently, 80% of AI projects fail.1 As with most paradigm-shifting technology, it…

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Is Your Organization Ready for AI Inspection?
July 10, 2026|
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Inspecting AI is not new to regulators. The expectations are already well-established. The key question is whether your organization can reliably demonstrate them. Written by Tracy Hibbs and Tony Sacchetti, Waters Corporation Exploring artificial intelligence (AI) and machine learning (ML) in regulated laboratories governed by Current Good Manufacturing Practices (CGMP) may be new for your…

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AI in GMP: Navigating Evolving Expectations for Regulated Labs
July 7, 2026|
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Why 2026 marks the shift from guidance to enforcement and what it means for your organization now. Written by Tracy Hibbs and Tony Sacchetti, Waters Corporation Regulators are already inspecting AI use, how prepared is your organization? For years, the pharmaceutical industry has anticipated regulatory clarity on the use of artificial intelligence (AI) and machine…

Staying Current: Why Upgrading Matters for Your Lab’s Future
September 16, 2025|
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In the fast-paced world of life sciences, staying current isn’t just a best practice, it is a necessity. As technology evolves, so do the risks of your lab falling behind and risking non-compliance with CGMP standards. With general releases of WindowsTM 10 Operating System reaching end of support on October 14, 2025,1 now is the…

Ready for What’s Next in Your Lab?
October 23, 2020|

In this series, we review considerations for keeping your lab at the forefront of science. As you adjust to living and working in a pandemic and anticipate future global and geopolitical events, Waters remains dedicated to supporting your business and unlocking the potential of your science. Our holistic separations solutions and expert support help you…