Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (6)
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| Document information | |
|---|---|
| Reference | USA 21 CFR Part 11 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 21 CFR Part 11 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 21 —Food and Drugs
Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 11 Electronic Records; Electronic Signatures https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 — Unit 4.2.3 |
| Scope | G |
| Document part | § 11.3
(b) (6) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Electronic records, Electronic signature, Definition, FDA |
Content
§ 11.3 Definitions […] (b) The following definitions of terms also apply to this part: […] (6) Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. [...]
