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Featured

Toon Lambrechts / Unsplash

Lessons From GAMP 5
Walter Nowocin
Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms. Yet few industry resources provide detailed, practical guidance for managing these processes effectively. One notable exception is ISPE’s GAMP 5: “A risk-based approach to compliant GxP computerized systems.” More…

Lean

A Quick Boost to Leadership Efficiency and Effectiveness

It’s hard to balance all the demands that are placed upon you as a leader. Many of us default to dysfunctional ways of spending our time and energy. If you know what the common mistakes are and take a more deliberate approach to investing your time and energy, you’ll get better results from your…

The Waste in Work’s Clothing

In my Labor Day article, “Celebrating Our Frontline Scapegoats,” I observed that of the seven wastes, the one most people recognize is defects. This is understandable: Workers are often blamed for defect-causing situations over which they have little or no control. This article continues that…

Manage Change

A vital concept from the chemical process industry, management of change (MOC) relates primarily to safety. It means that whenever we change a factor in a cause-and-effect diagram (e.g., machine, material, manpower, method, measurement, environment, or any other factor), we create risks of…

Analytic Hierarchy Process: The Art of Choosing Projects Wisely

Organizations often face a familiar dilemma: It’s not a shortage of good ideas, but a struggle to decide which one to pursue first. During project prioritization meetings, leaders are likely to present a wide range of perspectives. The finance team pushes for hard savings, while operations…

The Recalibration Secret

Everybody wants to have good measurements. To this end, many recommend a regular schedule of recalibration. While this sounds reasonable, it can actually degrade the quality of the measurements.

The key to getting the most out of a measurement process is to know when to…

Stop the Bleed: Reduce Costs, Not Capacity

Cutting costs is nothing new in manufacturing. What’s new is having to do it while juggling labor shortages, supplier delays, and tighter customer demands. Lean principles such as reducing waste and optimizing workflows still matter, but they’re no longer enough on their own. Staying competitive…

more articles
21st Annual Northeast Lean Conference
Oct. 27–28, 2025, DoubleTree by Hilton, Manchester, New Hampshire
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RealMan Showcases Robotics at Automate 2025
Intelligent, embodied robotic arms, modular platforms, and AI-powered medical solutions
Compliance Group Hosts Live Webinar on Digital pFMEA
Proactive manufacturing risk management and real-time alerts
BioIVT Deploys IDBS E-WorkBook
Reduces study times by at least 30%
Custom Manufacturing in 48 Hours
SendCutSend unveils expedited service
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