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Quality Assurance Standards in Healthcare

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AI has been part of healthcare technology for a long time. Image by Nappy on Unsplash

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Many people don’t realize just how long AI has been around in the healthcare industry—and are surprised to find out that it’s something that’s been relied on for 50 years already.

Create Authentic Connections With Virtual Team Members

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How do you keep co-workers connected when they are miles apart? Photo by Windows on Unsplash

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Four years after the Covid-19 pandemic accelerated remote work, its advantages and drawbacks have been well documented.

Avoid the ‘Blockbuster Effect’ in Life Sciences With Preventive Quality

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“Make it a Blockbuster night!” Credit: Sean Davis

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This year, the Medical Device Innovation Consortium held an Excellence in Quality Summit where it was promised that participants would receive a “uniq

Are Your Employees Empowered?

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Empowered employees provide better customer service. Photo by Vitaly Gariev on Unsplash

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Are your employees empowered to make decisions on the spot in favor of the customer? Your single goal should be to have overly happy customers. Too many things go wrong each day. You want your employees to understand they are in customer service, and their No.

Why the World Needs Responsible AI

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We stand on the brink of a new world powered by AI technologies. Photo by Greg Rakozy on Unsplash

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For the last 30 years, the JPEG image format has been a staple for the internet’s billions of users. While the technologies used to display images have evolved tremendously during the past few decades, the JPEG format is still used everywhere.

Twelve Ways to Assess Manufacturing Control and Analytics Software

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Photo by ThisisEngineering on Unsplash

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Whether you’re an executive with limited energy or an hourly employee trying to minimize work, the bottleneck in your productivity isn’t time or money but mental effort.

I Never Want to Be [Sic]k

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Always check spelling, but don’t rely on autocorrect—read it before you send it. Photo by Lance Grandahl on Unsplash

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Reading the news (or even your email) can be distressing to the point of despondency. It can also be fun.

What FDA QSR and ISO 13485 Harmonization Means for Medical Device Companies

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Photo by Lucas Vasques on Unsplash

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On Jan. 31, 2024, the U.S.

Twelve Strategies for Successful CAPA Management

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There’s no question about it: Should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system.

Measurement Rules of Thumb, Part 1

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Do rules of thumb apply? Photo by ål nik on Unsplash

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In this job, I get a lot of questions. In fact, I did some figuring the other day and estimated, conservatively, that we have probably answered at least 50,000 gauging questions over the past 35 years or so.

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