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 ...
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 ...
Pharma 4.0 integrates LIMS, AI algorithms, and digital twin technology to eliminate data silos and drive connected ...
Built-in data integrity is a bare minimum requirement in today’s BioPharmaceutical manufacturing. Good Manufacturing Practices (GMP) regulations of the Food and Drug Administration (FDA) highlight the ...