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Systems validation: application to statistical programs
BACKGROUND: 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 determining which systems should undergo validation. Since s...
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| Formato: | Texto |
| Lenguaje: | English |
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BioMed Central
2005
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC545946/ https://www.ncbi.nlm.nih.gov/pubmed/15649319 http://dx.doi.org/10.1186/1471-2288-5-3 |