How Much Value Is There in a Software Operational Qualification?

被引：0
|
作者：
McDowall, R. D.
机构：
[1] McDowall Consulting, R.D. McDowall Limited, Australia
来源：
SPECTROSCOPY | 2012年 / 27卷 / 12期
关键词：
Risk assessment;
D O I：
暂无
中图分类号：
O433 [光谱学];
学科分类号：
0703 ; 070302 ;
摘要：
Software operational qualification (OQ) is considered a mandatory item in a computerized system validation project for a regulated laboratory. But we should ask two questions: Is OQ really essential to a validation project for this type of software? How much value does a software OQ for commercially available software actually provide to a validation project?
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页码：14 / 17
页数：4
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