21 CFR Part 11, why does it confuse people so? This code addresses data integrity and security & electronic signatures.• Perhaps it is the meaning of raw data• Or maybe it is figuring out when my use of electronic signatures needs to meet FDA requirements• Is your software not sophisticated, and are wondering if you can use a USB to transfer raw data?• Possibly it is the rabbit hole of security or addressing the reliability of your data
Whatever your challenges are, Jackie Torfin, CEO of QLeaR Advisors, will help you strategize your approach to the FDA Code.