Change in FDA stance on Part 11 Requirements.
The United States Food and Drug Administration (FDA) has decided to reexamine its regulations for electronic records and signatures, and during this process, to reduce the enforcement of some of the provisions of the regulations. This article discusses FDA's decision and the content of its related, recently issued guidance document.
Donawa
Maria
M
donawa@srd.it
D001319:Authorship; D016494:Computer Security / Q000331:legislation & jurisprudence* / Q000592:standards; D003219:Confidentiality / Q000331:legislation & jurisprudence; D005568:Forms and Records Control / Q000331:legislation & jurisprudence / Q000592:standards; D019983:Guideline Adherence / Q000331:legislation & jurisprudence; D019451:Information Management / Q000331:legislation & jurisprudence* / Q000592:standards; D016247:Information Storage and Retrieval / Q000331:legislation & jurisprudence* / Q000379:methods / Q000592:standards; D016347:Medical Records Systems, Computerized / Q000331:legislation & jurisprudence* / Q000592:standards*; D011640:Public Policy; D014481:United States; D014486:United States Food and Drug Administration; D014584:User-Computer Interface