Recent Posts

  • Reset
young scientists working in laboratory

Is Your Organization Ready for AI Inspection?

Reading Time: 5 minutes

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...

adobestock 833539647 full res presentation ready png

AI in GMP: Navigating Evolving Expectations for Regulated Labs

Reading Time: 5 minutes

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...

laptop, scientist and women with smile, medical research and excited for results of test and pointing. lab, online and conversation for medicine of healthcare, pharmaceutical and collaboration

Reducing Risk, Rework, and Cost Through Chromatographic Stability

Reading Time: 3 minutes

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...

adobestock 971738341 empower screen full res presentation ready jpg

The Hidden Cause of Variability in Clinical LC-MS

Reading Time: 4 minutes

When variability appears in clinical liquid chromatography-mass spectrometry (LC‑MS) data, the mass spectrometer is often the first place that laboratories look. Changes in signal intensity, quantitative drift, or failed batches are frequently attributed to detector performance, ion optics, or acquisition settings. Chromatography is often the root cause of the variability observed at the mass spectrometer....

lost in the peaks image 2 full res presentation ready jpg

Retention Time Stability: The Foundation of Robust Clinical LC-MS

Reading Time: 3 minutes

In clinical liquid chromatography-mass spectrometry (LC‑MS), sensitivity and specificity often dominate the conversation. But behind every reliable result is a less visible parameter that determines whether workflows scale smoothly or struggle under pressure: retention time stability. As clinical laboratories increasingly rely on LC‑MS for high‑throughput, multi‑analyte testing, retention time stability has become a defining factor...