21 cfr part 11 subpart b electronic records July 8, 2019 16 32 64 128 Part 11 is the part of 21 cfr that deals with electronic records and electronic signature 21 cfr part 11 subpart b deals with following 21 cfr part 11 subpart b 11.10 Part 11 is the part of 21 cfr that deals with electronic records and electronic signatures