Scott Cleve brings an entire career dedicated to the mastery of global biopharma regulatory standards to his role as VP of regulatory operations and compliance at bluebird bio. Cleve joins the Business of Biotech podcast to discuss the regulatory trends shaping bluebird's pipeline of gene therapies for the treatment of serious, life-altering diseases. Listen now and subscribe so you never miss an episode.
This article presents some advice for auditing electronic batch records to assess their cGMP status. This is useful in the qualification stage and essential once the electronic record system is in operation.