Abstract
Over the past few years, system validation has increased dramatically in both importance and frequency. This paper is the result of an analytical summary of 314 cases of system validation conducted by Weinberg Associates. In 16 theses organized into three categories—regulatory, technical, and business—the question “What have we learned?” is addressed.
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References
1.
Hirsch
AF
. Good Laboratory Practices . New York : Marcel Dekker ; 1989 .
2.System Validation Standards . Dubuque, Iowa : Kendall/Hunt Publishing Company ; 1990 .
3.Good Automated Laboratory Practices (GALPs) . Research Triangle Park, NC : United States Environmental Protection Agency ; December 28, 1990 .
4.
Clark
S.
Society of Quality Assurance Meeting. Atlanta, GA: 1992 .
5.
Yourdon
E.
Decline and Fall of the American Programmer . New York : Yourdon Press ; 1992 .
6.
Diebold
J.
The Innovators . EP Dutton; 1990 .
7.Discussion with System Validation Committee. Pharmaceutical Manufacturers Association, 1991 .
