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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.
Mar 22, 2024 · CFR - Code of Federal Regulations Title 21. The information on this page is current as of Mar 22, 2024. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal...
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...
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.
Mar 20, 1997 · Title 21, part 11 of the Electronic Code of Federal Regulations.
(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.
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).
Mar 22, 2024 · Sec. 11.2 Implementation. (a) 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...
Mar 22, 2024 · CFR - Code of Federal Regulations Title 21. The information on this page is current as of Mar 22, 2024. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal...
Mar 20, 1997 · Electronic Code of Federal Regulations (e-CFR) 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
