Susan Schniepp, Regulatory Compliance Associates Inc., explains how AI and digital twins speed up pharma batch release and detect data integrity issues with human oversight. In part 2 of a 2-part ...
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 ...
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 ...
Digital twins function as synchronized, real-time operational mirrors, where divergence from the physical process triggers ...
Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from ...
Deloitte has noted that digital transformation in life sciences manufacturing can boost operational efficiency by ...
AINewsWire Editorial Coverage: Pharmaceutical manufacturing is undergoing a structural shift as regulators demand higher standards for contamination control, data integrity and operational ...
“Data-driven” is a bedrock principle of today’s pharmaceutical marketing. But how well are we keeping up with the tremendous amount of data available to us? It’s estimated that the average hospital ...
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