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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An Unpopular Opinion The recent court decision in American Clinical Laboratory Association (ACLA) v. FDA struck down the FDA’s rule regulating laboratory-developed tests (LDTs), ruling the agency lacked statutory authority. While the court was legally...
Read MoreEach year, the world dedicates a day to reflect on the incredible power of women leaders and the influence they wield. This year it was March 8th – International Women’s day. This photo, taken during...
Read MoreWhen I reflect on my career journey, one pivotal moment stands out in my memory. It was 1995—a year that would shape my professional narrative in profound ways. At the time, I held the somewhat...
Read MoreHow do you discern between two critical concepts within the realm of training: training effectiveness and training competence? While both are vital for optimizing performance, they address different aspects of the training process. Understanding the...
Read MoreAs the year winds down, many of us find ourselves swept up in the holiday hustle and the push to meet year-end goals. For QA professionals in the medical devices and pharmaceuticals sectors, this period...
Read MoreEver thought about who keeps the heroes (and sometimes villains) in check in your favorite action movies? That’s right—the fixer, the problem-solver, the behind-the-scenes mastermind helping to ensure everything goes according to plan. In the...
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