Zdrowie i gospodarka · 24.09.2001
Draft Guidance for Industry; Electronic Records; Electronic Signatures, Validation; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Validation." The draft guidance describes the agency's current thinking on issues pertaining to validating computer systems subject to part 11 (21 CFR part 11) requirements, to ensure that electronic records and electronic signatures are trustworthy, reliable, and compatible with FDA's public health responsibilities. Such validation is a requirement of part 11 of title 21 of the Code of Federal Regulations.