Are scanned or electronically generated regulatory documents be considered electronic documents subject to Part 11?

Documents generated electronically are subject to Part 11. The FDA has accepted scanned copies of printed documents with an original ‘wet signature’ (signed with ink) as “certified copies” of source documents required under 21 CFR Parts 56, 312, and 812. The term “certified copy” was defined in the December 2010 draft Electronic Source Documentation in Clinical Investigations and May 2007 Computerized System Used in Clinical Investigations guidance as: “A copy of original information that has been verified, as indicated by a dated signature, as an exact copy having all of the same attributes and information as the original.”