Marc Holfelder reports in the 30-minute webinar recording about the FDA law as well as audit examples of current findings.
In 1997, the U.S. Food and Drug Administration (FDA) enacted a law that defined the requirements for electronic data and electronic signatures for computer systems in the GMP environment - 21 CFR Part 11. What are the requirements for software systems to meet the classic 21 CFR Part 11 requirements? Why do all relevant software systems also have to be validated in the company? At the latest since the European harmonization with the FDA requirements, with the introduction of the new ISO 13485:2016 and the new MDR, the topic of validation of software systems has moved into the focus of auditors.