Qualification of Network Components and Validation of Networked Systems

Published on: 
BioPharm International, BioPharm International-10-01-2001, Volume 14, Issue 10

by Ludwig Huber at Agilent Technologies GmbH and Rory Budihandojo To comply with 21 CFR Part 11, your networked systems require the same validation and qualification steps as those for a single computer. Shared servers and multiple access also add requirements that are unique to networks. Italicized words in this article are defined in the "The Glossaryy" on the last page of the online version.