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fda 21 cfr 21021 cfr part 11 regulations21 cfr part 11 assessment21 cfr part 11 guidelines21 cfr part 11 requirements21 cfr part 11 guidance21 cfr part 11 summary21 cfr part 11 meaningtitle 21 cfr part 11docusign 21 cfr part 1121 cfr part 210fda part 210