Why pragmatic, risk-based quality systems may offer a smarter path for sponsors and CDMOs than compliance theater and ...

As an industrial engineer and digital transformation leader, I’ve worked across regulated industries—defense, aerospace and healthcare—where quality and compliance are paramount. Over the past few ...

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Have you ever watched a quality control team inspect a random, finished product only to discover a defect created weeks earlier? By then, the damage has already been done. If Shigeo Shingo (1909-1990) ...

There is now broad consensus that data-driven decision-making is essential to success in today’s highly competitive manufacturing environment. Customers’ price-consciousness, combined with demands for ...

With QMS/SCADA integration, operators can perform inspections within their SCADA interface, with automatic logging and immediate alerts when quality drift occurs. Unified platforms reduce licensing ...

The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.

Space Associates, Inc., a provider of advanced metrology and inspection solutions, announced new machine learning capabilities for its kSA Glass Breakage & Defect Detection tool. The enhancement adds ...

It was recently reported from a case study done by researchers at the University of Sheffield Advanced Manufacturing Research Centre (AMRC; Rotherham, U.K.) that a vision inspection system using 3D ...