The life sciences industry finds itself at a crossroads and the FDA just redrew the map for quality management in life sciences. AI isn’t just allowed—it’s expected.
While traditionally conservative in adopting new technologies, the sector now faces an explosion of AI capabilities in quality management systems. The FDA’s recent draft guidance, released in January 2025, provides a framework for evaluating and implementing AI technologies. After digesting the guidance and having worked closely with AI implementations in life sciences quality systems, it’s clear that successful implementation comes down to three fundamental questions.