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Is Your Organization Ready for AI Inspection?
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…
Recent Posts
What’s Really Happening Inside the Capsid of Norovirus VLPs?
Norovirus virus-like particles (VLPs) are structurally heterogeneous, built from a single capsid protein that self-assembles into multiple geometries, making full characterization by conventional mass spectrometry (MS) extremely difficult. A recent bioRxiv paper by Dr. Charlotte Uetrecht and colleagues at the Centre for Structural Systems Biology (CSSB) in Hamburg, Germany, in collaboration with Waters scientists, demonstrates...
Is it Possible to Have High Analytical Sensitivity and Robustness in Clinical Mass Spectrometry?
For decades, mass spectrometry (MS) developers and users have lived with a familiar trade‑off. Instruments designed for the highest analytical sensitivity often come with implicit costs: fragility, frequent maintenance, and performance that drifts under the pressures of routine use. Conversely, the most robust systems have sometimes been viewed as blunt tools—reliable workhorses, but lacking the...
AI Maturity in GMP: Accelerating Your Digital Journey at Warp Speed, Safely
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...
Is Your Organization Ready for AI Inspection?
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...
AI in GMP: Navigating Evolving Expectations for Regulated Labs
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...
Reducing Risk, Rework, and Cost Through Chromatographic Stability
As clinical LC‑MS adoption continues to grow across toxicology, endocrinology, therapeutic drug monitoring, and metabolic testing, laboratories face an increasingly difficult challenge: delivering results that are not only sensitive, but routine, reproducible, and economically sustainable. While investment decisions often focus on mass spectrometry (MS) detection, experience across clinical laboratories shows that chromatography is frequently the...
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