federal_register: 02-28551
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 02-28551 | Draft Guidance for Industry on Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records." This draft guidance describes the agency's current thinking on issues pertaining to furnishing FDA with electronic copies of electronic records that are subject to part 11. Part 11 requires persons to employ procedures and controls for records subject to part 11 that include the ability to generate electronic copies of electronic records that are accurate, complete, and suitable for FDA inspection, review, and copying. This requirement helps ensure that electronic records and electronic signatures are trustworthy, reliable, and compatible with FDA's public health responsibilities. | 2002-11-12 | 2002 | 11 | https://www.federalregister.gov/documents/2002/11/12/02-28551/draft-guidance-for-industry-on-electronic-records-electronic-signatures-electronic-copies-of | https://www.govinfo.gov/content/pkg/FR-2002-11-12/pdf/02-28551.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records." This draft... |