The AI Touch: Artificial Intelligence Could Boost Quality Systems, Cut FDA Inspections – But Is Industry Ready?
• By Shawn M. Schmitt
As the medical device industry begins to push the boundaries of artificial intelligence – exploring ways to use advanced AI systems to review, sort and process big data to find quality systems or product problems that would simply take too long for human eyes to see – FDA is also looking at ways to use AI for its own advantage. "AI will reduce investigational time and increase FDA's speed in taking action on a problematic firm," one agency official says. Meanwhile, a new Artificial Intelligence Initiative has been launched by Xavier University to better determine how AI can be used in the quality and regulatory space. Also: J&J subsidiary Janssen explains how it uses AI for quality and regulatory applications, and an expert from Shire tells how top management can be convinced that using artificial intelligence can save their firms money.
Pioneering device-makers that use advanced artificial intelligence systems to analyze their vast streams of data to pinpoint predictive outcomes for quality systems and marketed products could one day see fewer US FDA facility inspections, an agency official says.
Art Czabaniuk, program division director/district director for the Division of Pharmaceutical Quality Operations III within FDA's Office of Regulatory Affairs, foresees "great benefit from AI in the regulatory environment" –...
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