This article explores how a QbD-based approach to AI algorithm qualification can support regulatory alignment, lifecycle control, and scientific rigor across pharma manufacturing operations.
The authors have explored how a shift in organizational culture can transform AI from a mere technical tool into a true collaborative partner, enhancing human expertise and driving innovation. The authors have also shared how AI is revolutionizing quality assurance throughout the pharmaceutical manufacturing lifecycle, from raw material intake to predictive maintenance, delivering greater...
Pharmaceutical manufacturing faces mounting pressure to comply with stringent regulatory requirements while maintaining the highest standards of quality, speed, and efficiency. As digital transformation revolutionizes industries, artificial intelligence (AI) is emerging as a critical driver of change in reshaping how pharmaceutical companies operate. This article continues our exploration of...
This article explores what it takes to build a culture where human expertise and artificial intelligence complement one another, driving speed, precision, and innovation without sacrificing regulatory rigor.