Speed to patient is a primary driver behind the industry’s shift toward modern commissioning and qualification (C&Q) practices while still ensuring product quality and patient...

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...

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  For many pharmaceutical organizations, the FDA’s draft guidance on  Considerations  for Complying with 21...

Uninterrupted operations are essential in today’s pharmaceutical manufacturing environment. Facilities must deliver consistent output without sacrificing quality, even amid complex infrastructure demands, global supply pressures,...

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...