Standards
Even the smallest manufacturer would never consider using a typewriter to develop an invoice, or manage a sales prospect list from a Rolodex. So why, when it comes to quality management, are they often still using manual methods or home-brewed software that was never intended for today’s quality…
In 2021, container ships idled for weeks outside the Port of Los Angeles, a stark visual reminder of just how fragile modern supply-chain reliability had become. The backlog sent shockwaves across industries. Factories stalled, shelves emptied, and businesses scrambled for alternatives. It was a…
The arrival of artificial intelligence (AI) in quality management has been met with a mixture of hype and skepticism. Is it just a faster anomaly detector, or is it truly transformative?
The answer depends on how we frame the problem. If we see AI merely as a way to speed up…
The global coding- and marking-equipment market is on a clear growth path. As shown in a recent Grand View Research report, the market was worth $17,528 million worldwide by the end of 2024.
Furthermore, GVR’s projections estimate the market value will reach $24,927 million by…
My June 2025 article, “How to Avoid FDA Warning Letters,” points out that inadequate corrective and preventive action (CAPA) is a major reason for warning letters, and also introduces the role of failure mode effects analysis (FMEA) in preventing trouble in the first place. The U.S. Food and…
Ninety days to implementation vs. 12 to 18 months with traditional systems: That’s not just an incremental improvement—it’s a complete reimagining of what’s possible in life sciences quality management.
In the highly regulated life sciences industry, quality management system (QMS)…