As emphasis grows on managing data in pharmaceutical labs and plants—collecting and storing it, sharing it, mining it for pertinence—a basic question often goes unanswered: Is the data any good? The ...

Key market opportunities include gaining expertise in FDA compliance for computer system validation, implementing robust risk-based validation strategies, and addressing challenges in cloud, AI, and ...

Increased regulatory focus on data integrity violations in GxP inspections opens opportunities for pharma companies to invest in staff training and compliance strategies related to document management ...

The top generic drug regulator at the US Food and Drug Administration (FDA) on Wednesday touted the drop in refuse-to-receive ...

Looking to slow the fallout from Novartis’ data manipulation fiasco with its billion-dollar gene therapy Zolgensma (onasemnogene abeparvovec-xioi), CEO Vasant Narasimhan told an investor conference on ...