Drugs

Companies Can Use AI to Prepare for Inspections

With FDA using its artificial intelligence (AI) tool ELSA during inspections, regulated companies can better prepare for inspections by using their own AI tool. That’s the view of former FDAer David Elder. Writing in a Med Device Online guest column, Elder says using ELSA enables an FDA investigator to identify signals more quickly and comprehensively than previously used manual and computer-aided inspection tactics.

“FDA’s use of an AI tool is an inspection tactic that is here now and is here to stay,” Elder writes. “While currently in its infancy, its use will only evolve. With no benefit derived from resisting, ignoring, or feeling victimized by its use, the best logical path forward is to qualify an AI tool for company use, develop user competency in its functionality, and adapt the internal systems and approaches to embrace it.”

Given that an inspection should not find anything in a company’s data that the company didn’t already know, Elder says that using a qualified AI tool to supplement data trending and analysis within and across sources of quality data is encouraged. He says the AI-supported analyses, supported with additional human oversight, should be embedded within existing quality management systems and reported in ad hoc or standing committees and meetings.

“When implemented with adequate oversight and critical thinking,” Elder concludes, “a company’s use of its own properly qualified AI tool will strengthen inspection readiness and support more effective inspection management. Its greatest value, however, lies in its ability to enhance a company’s capability to identify and evaluate signals to better ensure product quality, patient safety, and regulatory compliance, while maintaining vigilant human oversight. Ultimately, organizations that remain committed to these priorities will continue to achieve successful inspection outcomes.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome