Is the estimation of measurement uncertainty a viable alternative to validation?

被引：2

作者：

Kuppers, S ^{[1
]}

机构：

[1] Schering AG, In Proc Control, D-13342 Berlin, Germany

来源：

ACCREDITATION AND QUALITY ASSURANCE | 1998年 / 3卷 / 10期

关键词：

chemical analysis; development process; measurement uncertainty; validation; practical examples;

D O I：

10.1007/s007690050275

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

Two examples of the use of measurement uncertainty in a development environment are presented and compared to the use of validation. It is concluded that measurement uncertainty is a good alternative to validation for chemical processes in the development stage. Some advantages of measurement uncertainty are described. The major advantages are that the estimations of measurement uncertainty are very efficient, and can be performed before analysis of the samples. The results of measurement uncertainty influence the type of analysis employed in the development process, and the measurement design can be adjusted to the need of the process.

引用

页码：412 / 415

页数：4

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