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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…
Pharmaceutical Serialization
Nimax
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 had…
Accountable When AI Fails?
Cornelia C. Walther
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 investigated the…
Strong QMS Is Central to the Med Device Right-to-Repair Movement
Heidi Drafall
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. The…
Semiconductor Equipment Manufacturing
Cadrex
The semiconductor manufacturing industry is undergoing rapid transformation driven by technological advancements, increased demand for AI and electric vehicle (EV) chips, and geopolitical shifts. Needless to say, the semiconductor industry and the companies that fabricate the equipment used in the…
Tabletop Factory-in-a-Box Makes Manufacturing Education More Accessible
Stefanie Koperniak
For more than a decade through a collaboration managed by MIT.nano, MIT and Tecnológico de Monterrey (Tec), one of the largest universities in Latin America, have worked together to develop innovative academic and research initiatives with a particular focus on nanoscience, nanotechnology, and,…
Ten Inventory Must Do’s
Adam Grabowski
Cash is king for manufacturers, from the owner down to the machine operators. If you visit any manufacturer, you’ll see that most have a keen eye on how everything is being used. Machines are generally only running if they are making parts; employees are typically only working if orders are coming…
Optimizing Production Efficiency
Akhilesh Gulati
Paul was sitting in his office staring at production numbers from the past quarter. Despite having a great team, strong customer demand, and state-of-the-art equipment, the factory’s performance wasn’t meeting expectations. There was a bottleneck in the assembly line—a critical chokepoint that was…
Solving a Supply Chain Puzzle
Akhilesh Gulati
It was another busy morning at the monthly operations meeting. Lindsay, the operations manager at TechElectronics, a growing manufacturer of consumer electronics, called the meeting to order. As usual, they started with the routine updates—inventory levels, production schedules, and customer…
Ten Rules for Brainstorming Success
Susan Robertson
Periodically, the popular press raises the idea that group brainstorming isn’t effective at generating creative solutions. That assertion is erroneous for a variety of reasons. Groups can—and do—successfully brainstorm creative and useful solutions. But research does show that effective…
What Does Office Work Have to Do With Production?
Bruce Hamilton
I was asked to lead a workshop in the sales order department of a manufacturer that we had helped with process improvement on the factory floor. Those efforts had positively reverberated across the company in the form of fewer late and expedited orders. Still, sales order employees were wondering…
How Trailblazing Manufacturers Are Using Generative AI in 2024
Jamie Fernandes-ETQ
Generative AI took the world by storm in 2023, from the classroom to the film studio, and the writer’s bench to the White House. Enterprises and creative industries worked to figure out how to leverage it in their operations, while classrooms and government entities struggled to govern its use. In…
Return to Office Does Not Mean Improved Mentoring
Gleb Tsipursky
Many leaders, driven by memories of pre-pandemic times, believe that forcing employees to return to the office will naturally lead to mentoring and development. For example, consider what Salesforce CEO Marc Benioff said in spring 2023 on the On With Kara Swisher podcast after the company demanded…
Improve Agile Methods by Encouraging Experimentation
Tina Behers
If the last few years have taught us anything, it’s how quickly—and drastically—things can change in business. Indeed, organizations have been in an almost constant state of change through the ebbs and flows of the pandemic and its new work models, the fluctuating economy, and labor challenges…
The Circular Economy: Building Trust Through Conformity Assessment
ISO
Economic practices need to change. The environmental and social consequences of unsustainable growth strategies are becoming increasingly obvious. A circular economy offers a way to counteract the climate crisis, strengthen our adaptive capacity, and make society more sustainable and resilient.…
Is Online or In-Person More Creative?
Susan Robertson
A debate you frequently hear in business circles is whether working online or in-person is more creative. The short answer? Both. Or neither. It’s solely dependent on how the meeting is structured and managed. When it comes to creativity, a recent study found that online interactions result in…
The AI Talent Squeeze Is Hurting Industry
Faustino Gomez, Sepp Hochreiter
With ongoing global shortages of all kinds of goods, from cars to lumber to cooking oil, both consumers and companies are struggling. The Russian invasion of Ukraine, along with renewed Covid outbreaks in China, are two things that are likely to make things worse before they get better. One way to…
Success Is Simple When You Let It Happen
The Un-Comfort Zone With Robert Wilson
Recently I was interviewed by Rocky Buckley, a strategic business coach and creator of the Power Persona Project. We discussed an aspect of success that I wish I could give to everyone: the concept of a positive temperament or mental state. So I decided to share the conversation. Rocky: Is success…
Cognitive Bias Is the Loose Screw in Critical Thinking
The Un-Comfort Zone With Robert Wilson
When I was a kid, I was enamored of cigarette-smoking movie stars. When I was a teenager, some of my friends began to smoke; I wanted to smoke too, but my parents forbade it. I was also intimidated by the ubiquitous anti-smoking commercials I saw on television warning me that smoking causes cancer…
Serendipitous Idea Generation for Hybrid and Remote Quality Teams
Gleb Tsipursky
‘I don’t see how we can replace the serendipitous idea generation of hallway conversations,” said Saul, the director of quality management for a 1,500-employee enterprise software company, during a planning meeting about the company’s post-vaccine return to the office. “If we don’t return to the…
A Dispatch and Routing Platform to Improve Deliveries
Zach Winn
More and more people are doing their shopping from home these days, and whether they’re ordering groceries, home office equipment, or Covid-19 tests, they increasingly expect their deliveries to be fast and on time. Companies have struggled to keep up with the rise in orders and expectations. One…
Managing Ideas With Employee Engagement and Collaboration
Tad Haas
According to Forbes, employees whose voices are heard are nearly five times more likely to feel empowered to perform their best work. Every team leader must keep their employees engaged and motivated so that they can benefit from their expertise. They can achieve this by taking a holistic approach…
Workplace Development Is the New Workforce Development
Matt Fieldman
This article is the fourth in a monthly series brought to you by the America Works initiative. As a part of the MEP National Network’s goal of supporting the growth of small and medium-sized manufacturing companies, this series focuses on innovative approaches and uncovering the latest trends in…
Are We Problem Solving or Just Going Through the Motions?
James Wells
I was talking recently with a friend who runs an academic program at a major U.S. university. She was telling me about solving a problem in her department and how the solution was obvious so she just did it. She then related how one of her colleagues protested that she should have used some Six…
Hold the Emoji and Other Tips for Successful Email Negotiations
Alena Komaromi
When your own inbox is overflowing with unread messages, it may not seem like the best tactic, but with the right approach, email can be a powerful negotiation tool, not least in the B2B realm. According to 2019 research by IACCM, a global contract management association, about 75 percent of…

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