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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.

The Power of Thought: How Critical Thinking Can Help Your Business

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Many people work on their goals by engaging in positive actions—hitting the gym, planning a trip, or taking guitar lessons. But they may be overlooking one of the most important tools for effecting change: the power of thought.

ANSI’s Role in the Wide World of Standards

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I love standards, and whether you know it, you love standards, too. For example, let’s say a bulb in your lamp goes bad. You drive down to the local hardware store, buy a bulb, come back home, change out the bulb, plug the lamp back in, and... it lights up.

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.

The Keys to Quality Assurance

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Managers the world over want to know if things are “in control.” This usually is taken to mean that the process is producing 100-percent conforming product, and to this end an emphasis is placed upon having a good capability or performance index.

NIST: Blockchain Provides Security, Traceability for Smart Manufacturing

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Engineers at the National Institute of Standards and Technology (NIST) needed a way to secure smart manufacturing systems using the

Here Today, Gone Tomorrow

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In the 1999 film Office Space, a dark comedy about the mundane conventionality of work, disgruntled software engineer Peter Gibbons tells his new love interest, Joanna, that he hates his job and doesn’t want to go anymore.

Design Robust Processes to Avoid ISO 9001:2015 Nonconformances

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Your audits don’t have to feel like this.
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The Pareto principle calls for focus on the vital few rather than the trivial many.

Pagination

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