Validated System, Uncontrolled Processes: Closing GxP Gaps in Your Lab
Many regulated labs have GxP-validated LIMS in place, but still rely on paper forms, spreadsheets, PDFs, and email to run a significant portion of day-to-day laboratory operations. Often, teams think about compliance primarily in the context of sample management. But the scope is much broader. Auditors do not just look at how labs log samples and record results in their LIMS. They also scrutinize how teams calibrate equipment, validate methods, investigate deviations, approve procedural changes, and trace reagents end to end. That scrutiny is also showing up more directly in FDA observations: 21 CFR 211.68(b) citations rose roughly 55% from 2022 to 2025.1
As regulatory scrutiny continues to intensify, the gap between what lives inside a GxP controlled environment–and what doesn’t–is getting harder to ignore.
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