Spring Cleaning, Quality Style
Hey, the days are growing longer, and the weather is warming up! It’s time to start thinking about spring cleaning our homes—a fresh start and a declutter! What if we applied this to our work,...
Read MorePrinting Electronic Data Doesn’t Solve Data Integrity Issues—Here’s Why
It happens multiple times a year when I interact with pharma, biotech, or medtech clients. We start discussing computerized system use and data integrity, and inevitably, I hear some variation of: “Our electronic data is...
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Quality Training (March) Madness
Maintaining a culture of quality and regulatory compliance is necessary in pharmaceuticals and medical devices. The consequences impact patient safety and organizational reputation and may have legal ramifications. So ongoing training is important, often bordering...
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Love Your Quality System: Navigating the Heart of Medical Device and Pharmaceutical Excellence
Exploring best practices for quality documentation, employee training, and internal audits of Quality Management Systems
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7 Tips for Success in 2024
As we usher in the promise of a new year, the field of quality compliance in medical devices and pharmaceuticals stands at the precipice of innovation, challenges, and boundless possibilities. To seize the opportunities ahead,...
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QSR Transition to QMSR
In early 2022, the US Food and Drug Administration (FDA) issued its proposed rule for medical devices, the Quality Management System Regulation (QMSR). This proposed rule connects and aligns 21 CFR Part 820 Quality System...
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The 12 Days of Quality
Deck the halls with boughs of…quality? That’s right! The holiday season is upon us, and while we’re busy spreading cheer and joy, let’s not forget to celebrate the unsung heroes of our industry – Quality...
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