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My continuing adventure with 21 CFR Part 11 - the evolution of Zymark's compliance
A renewed focus has been given to the 3-year-old regulation 21 CFR Part 11, Electronic Records and Electronic Signatures. This paper gives a chronology of the process of an equipment vendor, Zymark Corporation, validating laboratory automation equipment for compliance to the regulation 21 CFR Part 1...
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| Formato: | Texto |
| Lenguaje: | English |
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Hindawi Publishing Corporation
2001
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2562856/ https://www.ncbi.nlm.nih.gov/pubmed/18924710 http://dx.doi.org/10.1155/S1463924601000232 |