In today’s highly regulated life sciences industry, data integrity is not just a compliance requirement; it is fundamental to ensuring product quality, patient safety, and operational success. However, despite significant advancements in technology and regulatory frameworks, the FDA continues to issue warning letters tied to data integrity issues. In fact, 20% of all FDA warning […]
In today’s rapidly evolving life sciences industry, the drive toward digital transformation is no longer a luxury—it is a necessity. As companies seek to enhance operational efficiency, ensure regulatory compliance, and improve overall product quality, digital tools and automation are leading the way. In this blog, I will outline how digital transformation serves as the […]
In the rapidly evolving pharmaceutical industry, the rising costs of drug development present significant challenges. From the 1970s to the 2020s, development costs have increased dramatically, posing hurdles for biotech and pharmaceutical companies. Contract development and manufacturing organizations (CDMOs) have become a strategic solution, with the global CDMO market projected to grow significantly in the […]
Director of Technical Services - Donna has over 20 years of experience leading teams in Commissioning, Qualification, and Validation (CQV). Her focus has always been on pioneering equipment management, quality control, and embracing innovative practices, such as Paperless Validation.