Data Integrity and Document Management in the GxP Pharmaceutical Lifecycle (GCP, GMP, GLP and GvP): Latest MHRA Data Integrity Guide and EMA TMF Guideline (ONLINE EVENT: June ...

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 ...
MedCity News

Ensuring Data Integrity in BioPharmaceutical Manufacturing: The Need for Contextualization and Cloud-based Integration

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 ...
PharmTech

Identifying Data Integrity Hotspots Using AI Technology

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 ...
PharmTech

Digital Twins and the Future of Pharma Validation

Susan Schniepp, Regulatory Compliance Associates Inc., discusses digital twins and AI in pharma, focusing on data integrity, human-in-the-loop roles, and evolving machine learning risks. In part 1 of ...
Labroots

Microbial testing for the pharmaceutical industry: A straightforward path toward regulatory compliance, data integrity, and computer systems validation

Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from ...
TMCnet

AI-Powered Pharma Manufacturing Signals Scalable Efficiency, Long-Term Cost Advantages

Deloitte has noted that digital transformation in life sciences manufacturing can boost operational efficiency by ...