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Digitizing the Paper Chase.
- Source :
- Drug Discovery & Development; Jun2006, Vol. 9 Issue 6, p54-58, 3p
- Publication Year :
- 2006
-
Abstract
- The article discusses the United States Food and Drug Administration's rules for digitizing documents in filing new drug applications. The FDA issued Code of Federal Regulations Title 22, Part 11 defining the requirements for electronic record keeping and submission by pharmaceutical companies such as standards in digital signatures on documents and levels of security and accountability that must be built into the software that handles the data.
- Subjects :
- DRUG approval
DRUG development
ONLINE data processing
PHARMACEUTICAL industry
Subjects
Details
- Language :
- English
- ISSN :
- 1524783X
- Volume :
- 9
- Issue :
- 6
- Database :
- Complementary Index
- Journal :
- Drug Discovery & Development
- Publication Type :
- Periodical
- Accession number :
- 21320024