Αποτελέσματα Αναζήτησης
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) to which such submissions may be made.
This document provides guidance to persons who, in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA 3, have chosen...
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).
22 Μαρ 2024 · 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. Subpart...
Title 21 CFR Part 11 brings FDA regulations into the digital age by allowing electronic documents and signatures on official government business. This affects industries regulated by the FDA, including: Drug manufacturers. Medical device producers. Biotech. Biological developers.
3 These requirements include, for example, certain provisions of the Current Good Manufacturing Practice regulations (21 CFR Part 211), the Quality System regulation (21 CFR Part 820), and...
The purpose of Part 11 is to ensure that electronic records and electronic signatures can be trusted as much as paper records and ink signatures.
22 Μαρ 2024 · Sec. 11.1 Scope. (a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to...
22 Μαρ 2024 · 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...
(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.
