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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.

Data Management and Reporting in FDA-Regulated Clinical Trials

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Using a single, centralized electronic data capture system helps you stay compliant and eliminates unnecessary regulatory burden. Photo by Olga Guryanova on Unsplash

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Ensuring the accuracy and security of clinical data, as well as compliance with good clinical practice (GCP), will in large part determine the success of your study and regulatory submission to the U.S. Food and Drug Administration (FDA).

Building a Sustainable Path to ESG Reporting

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Global awareness of climate change and sustainability has grown exponentially during the past decade, making terms like corporate responsibility

Customer Fog: The Real Reason Customers Leave

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There’s the exit. Have you made it easy to walk away? Photo by Viktor Forgacs on Unsplash

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The cost of acquiring a new customer can be five to 10 times the cost of keeping an existing customer, depending on the industry. You already knew that.

Child Labor Law Compliance in Manufacturing

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Child labor violations have increased 88% since 2019. Photo by Vitolda Klein on Unsplash

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For the U.S. Department of Labor’s Wage and Hour Division, protecting children in the workplace is the top priority.

Maintenance Incident Reports

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Photo by Ümit Yıldırım on Unsplash

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Maintenance teams operate in challenging environments that can often produce workplace mishaps, near misses, and other potential hazards. That’s where maintenance incident reports come in.

Accounting for Sustainability

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Sustainability is where finances and ESG converge. Photo by Towfiqu barbhuiya on Unsplash

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In today’s business environment, where the insatiable desire to grow profits overshadows environmental and social interests, it’s easy to overlook how the actions of economic actors can shape corporate—and environmental—outcomes.   

Pagination

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