Document Detail


Change in FDA stance on Part 11 Requirements.
MedLine Citation:
PMID:  12789696     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Maria Donawa
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Medical device technology     Volume:  14     ISSN:  1048-6690     ISO Abbreviation:  Med Device Technol     Publication Date:  2003 Apr 
Date Detail:
Created Date:  2003-06-06     Completed Date:  2003-07-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9215490     Medline TA:  Med Device Technol     Country:  England    
Other Details:
Languages:  eng     Pagination:  24-6     Citation Subset:  T    
Affiliation:
donawa@srd.it
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MeSH Terms
Descriptor/Qualifier:
Authorship
Computer Security / legislation & jurisprudence*,  standards
Confidentiality / legislation & jurisprudence
Forms and Records Control / legislation & jurisprudence,  standards
Guideline Adherence / legislation & jurisprudence
Information Management / legislation & jurisprudence*,  standards
Information Storage and Retrieval / legislation & jurisprudence*,  methods,  standards
Medical Records Systems, Computerized / legislation & jurisprudence*,  standards*
Public Policy
United States
United States Food and Drug Administration
User-Computer Interface

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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