Fda cfr 21 part 11 annex 1 July 8, 2019 16 32 64 128 Fda 21 cfr part 11 eu annex 11 Fda 21 cfr part 11 annex 11 Fda 21 cfr part 11 annex 11 gamp tm 5 assessment Fda 21、cfr part 11、eu gmp annex 11 Fda 21 cfr part 11