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21 cfr part 11 compliance21 cfr 1121 cfr part 11 compliance assessmentfda 21 cfr part 11 compliance21 cfr part 11 assessment checklist21 cfr part 1121 cfr validation21 cfr part 11 regulations21 cfr part 11 guidelines21 cfr part 11 certification21 cfr part 11 assessment21 cfr part 11 guidance