Qualification of Network Components and Validation of Networked Systems, Part I

I n Part I of this article, the authors discuss FDA expectations, specific requirements, and validation plans of networked systems and include a glossary of related terms. Part II will address the types of specifications, the installation, testing, and implementation of required validation for networks.

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Author(s): 
Ludwig Huber* ,Rory Budihandojo.
Journal: 
Pharmaceutical Technology OCTOBER 2001.