Electronic record

Part 11 applies when records required by FDA rules are kept electronically. FDA's Part 11 scope and application guidance narrowed its practical reach, so companies focus on records that FDA requirements call for and on systems that hold them.

(6) Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

21 CFR, 11.3

combination of text, graphics, data, audio, imaging, or other information in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system (3.13) EXAMPLE An electronic CRF.

ISO 14155:2020, clause 3.21