COMPUTER SYSTEM VALIDATION

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Submitted by Rashmin on Tue, 07/08/2008 - 18:25.

Publication Type:

Web Article

Authors:

Rashmin B. Patel and Mrunali R. Patel

Source:

(2008)

Abstract:

FDA guidelines apply to all software and hardware used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality systems used in an environment where decisions produced by those systems can affect a product safety, purity or efficacy. Validation is the process of compiling written verification of all system functions and the performance of those functions to system specifications, as well as data integrity and system maintenance. That written documentation must be in alignment with the industry standards and regulatory laws that guide the FDA in their evaluation and enforcement of regulatory compliance. The ultimate goal of any computer system validation project is to realize and sustain compliance, while ensuring the peak performance and functionality of those systems.

Full Text:

Available at: http://www.ibpassociation.org/IBPA_articles/July2008issue/COMPUTER%20SYS...