ICT01: Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures
Delivered Online On Demand1 hour 30 minutes
Information and Communication Technology
Our course on US Regulation 21CFR11 explains what needs to be done to ensure that computer systems in environments regulated by the Food and Drug Administration (FDA) comply with the regulation.
Our module ICT01 clarifies the complicated picture of regulatory requirements and enforcement discretion applying to computer systems operated by companies that market or intend to apply for approval to market drugs or medical devices in the USA and by suppliers to those companies.