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What to Expect During an FDA QSIT Inspection

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You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US.

On the Road to Big Medicine

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Life science companies are no strangers to data, so it would be easy to assume they are adept at making innovative use of huge amounts. Not necessarily.

Big Data: Your Health vs. Your Privacy

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For centuries, medical procedures, prescriptions, and other medical interventions have been based largely on experience—what is known about a set of symptoms.

Ensuring Food Safety With Quality Management Software

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In 2013, thousands of consumers in the United Kingdom (UK) and Ireland bought, prepared—and ate—beef lasagna, hamburgers, and frozen dinners. What they didn’t know is what they were actually putting in their mouths.

Improve Risk Management and Quality Across the Value Chain by Increasing Visibility

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Imagine building a brand over decades. Hundreds of millions of dollars invested in design and development. Sponsorships with celebrity athletes and professional and college teams. Leading-edge marketing making your company one of the top 20 brands in the world.

Three Philosophers Set Up a Booth on a Street Corner

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The life choices that had led me to be sitting in a booth underneath a banner that read “Ask a Philosopher” at the entrance to the New York subway at 57th and 8th were perhaps random but inevitable.

I Studied Buttons for Seven Years

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All day every day, throughout the United States, people push buttons—on coffee makers, TV remote controls, and even social media posts they “like.” For more than seven years, I’ve been trying to

What Would Happen If Hospitals Openly Shared Their Prices?

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Imagine there was a store where there were no prices on items, and you never knew what you’d pay until you’d picked out your purchases and were leaving the shop. You might be skeptical that the store would have any incentive to offer reasonable prices.

Have You Digitized Your Journey Map?

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In the past, I’ve written about some of the myths of journey mapping. One of those myths is: Without a digital mapping platform, I can’t even begin to map.

Welcome to a Special Report on Life Sciences

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I am thrilled to introduce Quality Digest’s special report, “Unlocking the Future of Life Sciences.” This series explores the last several decades of quality management within the life sciences industry.

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