CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
网页2024年3月22日 · 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 9....
21 CFR Part 11 -- Electronic Records; Electronic Signatures
网页This docket will identify specifically what types of documents or parts of documents are acceptable for submission in electronic form without paper records and the agency receiving unit (s) (e.g., specific center, office, division, branch) …
Part 11, Electronic Records; Electronic Signatures - Scope and ...
网页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...
Title 21 CFR Part 11 - Wikipedia
网页Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES).
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
网页2024年3月22日 · Sec. 11.100 General requirements. (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. (b) Before an organization...
eCFR :: 21 CFR Part 11 -- Electronic Records; Electronic Signatures
网页View Title 21 on govinfo.gov; View the PDF for 21 CFR Part 11; These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the CFR. Learn more.
21 CFR 11 - eCFR - Electronic Code of Federal Regulations e-CFR
网页1997年3月20日 · Title 21, part 11 of the Electronic Code of Federal Regulations.
网页regulations (21 CFR Part 211), the Quality System regulation (21 CFR Part 820), and the Good Laboratory Practice for Nonclinical Laboratory Studies regulations (21 CFR Part 58).
eCFR :: 21 CFR Part 11 Subpart A -- General Provisions
网页This docket will identify specifically what types of documents or parts of documents are acceptable for submission in electronic form without paper records and the agency receiving unit (s) (e.g., specific center, office, division, branch) …
网页(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.