June 3, 2025
In May 2023, the International Council for Harmonization (ICH) released the Step 2 draft of ICH E6(R3) for public consultation. This transformative update marks a significant milestone in the evolution of Good Clinical Practice (GCP). On May 22, 2024, the ICH announced the final Step 5 version of ICH E6(R3), a transformational update to the […]
May 22, 2025
MedTech: A Growing Industry for Mergers and Acquisitions The MedTech industry creates life-changing products to improve patient care. Companies in this field often merge, buy, or sell to grow their businesses. But these deals do not always succeed. Problems can arise when companies do not plan well or fail to focus on quality. A strong […]
May 22, 2025
The Cost of Poor Quality (COPQ) in the healthcare sector—particularly in medical devices, pharmaceuticals, and biopharmaceuticals—has profound implications for patients, employees, and shareholders. This analysis delves into the impact of the cost of poor quality across these key stakeholder groups. Impact on Patients Poor quality in healthcare can lead to severe consequences for patients, including: […]
May 22, 2025
In today’s rapidly evolving regulatory landscape, ensuring a robust quality culture is essential for any organization in the biopharmaceutical industry. Our latest infographic below offers a clear visual guide on how Compliance Architects can help you map out your quality strategy over the next three years. See the infographic below. The Journey Begins: Check Your […]
May 15, 2025
A Quality Professional’s Perspective on Why Change Management Efforts Fail When you get to the point of your career I now find myself in, you will have seen many change management efforts falter or fail. While some common themes and pitfalls contribute to all such failures, I want to emphasize those that I think are […]
May 14, 2025
“Quality is never an accident; it is always the result of Intelligent effort.” …John Ruskin I have spent the last 20+ years in the biopharmaceutical industry. My journey began modestly, starting with washing lab glassware, researching, and working as a QC environmental monitoring sampler. From there, I advanced to line supervisor and lab manager roles, […]
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