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

被引：0

作者：

S. Küppers

机构：

[1] Schering AG,

[2] In-Process-Control,undefined

[3] Müllerstrasse 170–178,undefined

[4] D-13342 Berlin,undefined

[5] Germany Tel.: +49-30-468-1-7819 Fax: +49-30-468-9-7819 e-mail: stephan.kueppers@schering.de,undefined

来源：

Accreditation and Quality Assurance | 1998年 / 3卷

关键词：

Key words Chemical analysis; Development process; Measurement uncertainty; Validation; Practical examples;

D O I：

暂无

中图分类号：

学科分类号：

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：3