: View the most current, searchable version at the Electronic Code of Federal Regulations (eCFR) . You can use the "Print/PDF" feature there to generate a local copy.
: Applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any FDA record requirements. Download Part11 txt
The regulation is divided into three main subparts designed to ensure that electronic records are as trustworthy as paper ones. : View the most current, searchable version at