Patient access to cell and gene therapy products will be tied to our ability as an industry to manufacture these therapies locally or at point-of-care. Not only are these products complex biologics but the quality systems that need to be in place to control the quality of the product are essential. Pharmaceutical QMS systems are critical to delivering on product quality. Innovation in digital systems to manage the traceability of starting material to patient dosing are in progress. In this podcast, Carol Houts will explore with Lynn Fischer and Najib Rehman what key strategies are in use today and discuss where we still see gaps and need for innovation.