Systems validation: application to statistical programs
<p>Abstract</p> <p>Background</p> <p>In 2003, the United States Food and Drug Administration (FDA) released a guidance document on the scope of "Part 11" enforcement. In this guidance document, the FDA indicates an expectation of a risk-based approach to deter...
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| Format: | Article |
| Language: | English |
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BMC
2005-01-01
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| Series: | BMC Medical Research Methodology |
| Online Access: | http://www.biomedcentral.com/1471-2288/5/3 |