In response to a landmark FDA warning, this analysis explores how regulators are shifting from automation to accountable stewardship, redefining governance expectations for AI across...

The release of the ISPE Baseline® Guide Volume 5 (Second Edition) QRM Addendum- C&Q Delivery Process and ASTM E2500-2025 marks a significant step forward for...

How evolving inspection expectations, digital manufacturing, and AI-enabled quality systems are reshaping pharmaceutical control strategies.  For many pharmaceutical organizations, the FDA’s draft guidance on  Considerations  for Complying with 21...

Chromatography in Biologics Manufacturing: Science, Purpose, and Resin Applications  Chromatography is a critical purification technique used in many evolving fields of biologics manufacturing including monoclonal...

Written by Paige Kane, PhD, CPIP   If you work in Life Sciences, you know that it is a complex, high-stakes operation.  I’ve been through my...

The Windsor Framework (WF), which came into effect on January 1, 2025, is a significant agreement between the UK and the EU that replaces the...

Pharmaceutical companies today face a high-stakes equation: launch faster, meet global demand, and maintain quality and compliance—without fail. That means simultaneously spinning up manufacturing sites,...

As global regulations continue to evolve, life sciences companies are facing increasing pressure to meet stringent compliance requirements without slowing down innovation or compromising product...

Nick Armstrong, Senior Director of Digital Enablement at CAI and co-chair of the ISPE Community of Practice on AI, specializes in the intersection of artificial...