Technique / Pharmacology and Toxicology
21 CRF Part 11 introduction
21 CRF Part 11 introduction
21 CRF Part 11 is a web site dedicated to information sharing on FDA 21 CRF particle 11. The site is maintained by Waters Corporated. It hosts a email list
that actively discusses issues and concerns on 21 CRF part 11 with industry and government regulators. The site also provides an information rich library on 21 CRF part 11, FAQ on 21 CRF part 11, the latest conference, meeting and seminar information as well as links to vendors and consultants specific to 21 CRF part 11 regulations compliance.
Title 21 Code of Federal Regulations (21 CFR Part 11)
Electronic Records; Electronic Signatures
Final Rule Published in the Federal Register
SUMMARY: The Food and Drug Administration (FDA) is issuing regulations that provide criteria for acceptance by FDA, under certain
circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, are intended to
permit the widest possible use of electronic technology, compatible
with FDA's responsibility to promote and protect public health. The use of electronic records as well as their submission to FDA is voluntary.
Elsewhere in this issue of the Federal Register, FDA is publishing a
document providing information concerning submissions that the agency
is prepared to accept electronically . http://www.fda.gov
The Code 21 of Federal Regulations (CFR) Part 11 resources:
FDA 21 CRF part 11 (PDF from FDA)
21 CRF part 11 resource
Last update 20-Nov-2008, Rating of 0 votes.
