Documents generated electronically are subject to Part 11. For documents that are printed out, signed with ink, and scanned, the FDA has accepted scanned copies of “signed paper documents,” which were considered to be “certified copies” of source documents that were required under 21 CFR Parts 56, 312, and 812. The term “certified copy” was defined in the new 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.”
