FDA--Food and Drug Administration CFR--Code of Federal Regulations This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11) Subpart A--General Provisions Sec. 11.1 Scope. (a) The regulations in this part s...
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