The January 8th webinar will explore the significance of 21 CFR Part 11, a regulation critical for FDA-regulated companies transitioning to electronic records. The session will clarify how Part 11 extends beyond standard IT security by integrating specific measures for controlling electronic signatures and maintaining the integrity of electronic records, as outlined in FDA guidance. The regulation aims to balance the efficiency of electronic records with FDA’s priority on ensuring patient safety and preventing data compromise.
Participants will gain insights into the regulatory framework, including the differences between open, closed, and hybrid systems, as well as the technical and procedural validation requirements for Part 11 compliance. The webinar will also address confusion stemming from the FDA’s initial regulation and its selective enforcement policy. By understanding these guidelines, companies can better navigate the intersection of data security and patient safety in FDA-regulated environments.