Opportunities lie in enhancing data integrity auditing skills within pharmaceutical manufacturing, focusing on GxP audits. Companies can capitalize by offering comprehensive training that delves into ...
"EMA will now review all available data to assess whether this emerging information has an impact on the balance of benefits and risks of Tavneos," said the EU regulator. "The agency will then issue a ...
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a review of Amgen’s Tavneos (avacopan), ...
This guide explores how regulated laboratories can achieve strong data integrity by digitalizing key processes ...
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 ...
Market growth underscores rising demand for data integrity, automation, and compliance-ready digital platforms across global pharmaceutical operationsDelray Beach, FL, Jan. 27, 2026 (GLOBE NEWSWIRE) - ...
Strengthen information governance with clear policies for data classification, retention, and legal holds to meet industry regulations and ensure defensibility. Embed compliance and collaboration ...
Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from ...
Data integrity is an ongoing concern across all R&D organizations, no matter what part of the research lifecycle they’re navigating. These concerns extend beyond the potential for delayed timelines or ...
The pharmaceutical industry is undergoing a seismic transformation, driven by the integration of data science and analytics. As the demand for novel therapies and personalized medicine surges, leaders ...