Spark Therapeutics

At the 2024 edition of the Biomanufacturing World Summit series we sat down with John H. Adams, Jr., Spark Therapeutics’ Senior Director, Validation, to talk about Computer Software Assurance in the Life Sciences. John has been doing Computer Systems Validation (CSV) for decades as a regulatory requirement, so when talk of a risk-based Computer Software Assurance (CSA) requirement started making the rounds, he was interested to understand the differences so he could best stay ahead of the compliance curve and ensure his best practices were not out of step with expectations. In this episode, John walks us through where the conversation between industry and regulators currently stands, what validation professionals should already be doing, what they should continue to do, what they should confirm they are doing correctly, and what they should prepare themselves for if and when current guidance becomes new regulations. For everyone in the Life Sciences who cares about the compliance of manufacturing systems, give this episode a listen!