FDA 21 CFR Part 11 Part11.Scope: Scope and implementation (21 CFR §§11.1-11.2)

Section 11.1 (Scope): the rules in this part set forth the criteria under which the agency considers electronic records + electronic signatures + handwritten signatures executed to electronic records to be trustworthy + reliable + equivalent to paper records + handwritten signatures executed on paper. Section 11.1 applies to records in electronic form that are created + modified + maintained + archived + retrieved + transmitted under any records requirement set forth in agency regulations. Section 11.2 (Implementation): for records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures provided that the requirements of Part 11 are met. Section 11.2(b) for records submitted to the agency, persons may use electronic records in lieu of paper records provided that the requirements of Part 11 are met + the documents have been identified in public docket No. 92S-0251 as being the type of submission the agency accepts in electronic form. Section 11.2(b) electronic submissions to the FDA include 21 CFR §11 Subpart B electronic records + the FDA's eCTD (electronic Common Technical Document) submissions framework for drug applications + the related eMDR + eSubmissions for medical devices.