Zdrowie i gospodarka · 8.04.2004
Electronic Record; Electronic Signatures; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting to discuss various topics concerning our regulations on electronic records and electronic signatures in part 11 (21 CFR part 11). FDA has begun to re-examine part 11 as it applies to all FDA- regulated products. We will consider the input from the public meeting and comments on the topics presented in this document as we evaluate potential changes to part 11.