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21 cfr part 11 regulations21 cfr part 11 assessment21 cfr part 11 software21 cfr part 11 meaningdocusign 21 cfr part 1121 cfr part 11 fda guidance21 cfr part 11 compliance statement21 cfr part 11 compliance assessment21 cfr part 11 compliance checklist21 cfr part 11 compliant software21 cfr part 11 assessment checklist21 cfr 820 part 11