CFR 21CFR Part 11

The Food and DrugAdministration (FDA) is issuingregulations that provide criteria foracceptance by FDA, under certaincircumstances, of electronic records,electronic signatures, and handwrittensignatures executed to electronicrecords as equivalent to paper recordsand handwritten signatures executed onpaper. These regulations, which applyto all FDA program areas, are intendedto permit the widest possible use ofelectronic technology, compatible withFDA?s responsibility to promote andprotect public health. The use ofelectronic records as well as theirsubmission to FDA is voluntary.Elsewhere in this issue of the FederalRegister, FDA is publishing a documentproviding information concerningsubmissions that the agency is preparedto accept electronically.

Product Details

Published:

04/01/2003

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1 file , 55 KB