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Featured

A. Boss/NIST

A team of NIST researchers, including Srivalli Telikepalli (shown here), developed a standard reference material that will help biopharmaceutical companies better detect these particles in their drug products.

New NIST Reference Strengthens Quality Control for Biological Drugs
NIST
A rapidly growing category of drugs called protein-based biotherapeutics can be used to treat cancers and genetic and autoimmune disorders. These drugs, which usually take the form of large protein molecules, are manufactured by growing living cells that are genetically engineered to produce the proteins. These large protein molecules, however, can stick together during the manufacturing process…

Supply Chain

5 Essential Elements Shared by Leading Supplier Quality Management Systems

Global-scale events have tested the bounds of supply chain systems. The coronavirus, for example, made it clear how critical an efficient supply chain is for continuity and survival. It’s a real-world example of how important it is to have an enterprisewide system that uses a quality management…

Pharmaceutical Serialization

Pharmaceutical serialization practices are on the rise and have progressively become a worldwide standard as a result of stringent regulations in various of markets, including the United States, European Union, China, and Argentina. Recent estimations found that by 2022 serialization practices…

Accelerating Hardware Development to Improve National Security and Innovation

Modern fighter jets contain hundreds or even thousands of sensors. Some of those sensors collect data every second, others every nanosecond. For the engineering teams building and testing those jets, all those data points are hugely valuable—if they can make sense of them.

Nominal…

Supplier Scorecards vs. Spreadsheets

Spreadsheets are usually the first tool used to manage suppliers, and the first to become a liability. Important updates get buried. Repeat supplier problems start popping up. Along the way, you start to wonder whether that cheaper vendor is really saving you money in the long run.

…
Accountable When AI Fails?

On April 8, 2025, a driverless Zoox robotaxi misjudged an approaching vehicle, braked too late, and sideswiped it at 43 mph on the Las Vegas Strip.

One month later, the Amazon subsidiary issued a software recall on 270 autonomous vehicles and suspended operations while regulators…

Strong QMS Is Central to the Med Device Right-to-Repair Movement

Anyone who has cracked their smartphone screen or had a rapid oil change knows that sometimes the OEM isn’t the most affordable or convenient service option. Consumer flexibility, paired with lower-cost, high-quality options, is logical, whether it’s in the consumer market or in healthcare.…

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