
Sample Labeling and Traceability Standards in the U.S.
A mislabeled sample is not a paperwork problem. It is a patient safety event, a regulatory citation, and — depending

A mislabeled sample is not a paperwork problem. It is a patient safety event, a regulatory citation, and — depending

Mention GLP and GMP in the same sentence to anyone working in a U.S. pharmaceutical contract lab, and you’ll get

The compliance landscape for FDA-regulated laboratories is not a monolith. It’s a patchwork of overlapping citations- and knowing which regulation

Fires don’t send calendar invites. Neither do floods, power surges, or HVAC failures. Yet most regulated laboratories are far better

When a batch of drug product fails stability testing at the 12-month mark, the first question regulators ask isn’t about

When you inspect any food and beverage QA lab during a production run and you’ll see some version of the

Most laboratories that delay adopting a Lab Information Management System cite one reason above all others: fear of disruption. Here is why

Ask most lab managers what their biggest operational challenge is, and they will probably say staffing, budgets, or turnaround times.

When a regulatory inspector cites a laboratory for sample management deficiencies, the observation rarely reads as “samples were mishandled.” It

In water testing laboratories, operational pressure tends to build quietly. It shows up in sample backlogs, in missed holding times,
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