This week, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced that its new guidance on good practices for data management and integrity for pharmaceutical manufacturers and ...
As is true in most industries, adoption of AI and machine learning (ML) is real and accelerating across the biopharma industry. However, most use cases center around applicatio ...
The COVID-19 public health emergency has prompted regulators to take a different approach to uncovering data integrity violations in virtual inspections compared to onsite inspections, said an ...