Validation in Chemical Measurement

Validation in Chemical Measurement

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Validationofmeasurementmethodshasbeenusedforavery ciated measurement uncertainty? The answer must be: no. longtimeinchemistry. Itismostlybasedontheexamination Therecanneverbeamechanismorrecipeforproducing - of a measurement procedure for its characteristics such as tomatically valid results because one can never eliminate precision, accuracy, selectivity, sensitivity, repeatability, re- theskills, theroleandtheresponsibilityoftheanalyst. producibility, detectionlimit, quanti?cationlimitandmore. ISO 9000:2000, item 3. 8. 5 de?nes validation as con?r- When focussing on quality comparability and reliability mation by examination and provision of objective evidence in chemical measurement, the ?elds of interest to this Jour- that the requirements for an intended use are ful?lled . The nal, one stumbles into various interpretations of the term revised edition of the VIM ( VIM3 ), is likely to ?ne-tune validation. It is one more example of a term which is used thisde?nitionoftheconcept validation tobe con?rmation sometimes very consistently, sometimes very loosely or in- through examination of a given item and provision of - deed ambiguously. Since the term is very common in the jective evidence that it ful?lls the requirements for a stated chemical community, it is important that its meaning be intendeduse . nd clear. Turning to the 2 edition of the International Vo- Lookingatsimplepractice, manypeoplearelookingfor cabulary of Basic and General terms in Metrology (VIM) aformaldecisionthatagivenmeasurementmethod automat- (1993), surprisingly we do not ?nd a de?nition. Webster s ically gives them valid i. e. reliable results. One wonders Dictionary of the English language (1992) tells us that val- what this has to do with stated intended use . Reliab- idation is making or being made valid . Obviously valida- ity clearly is a property of a measurement result.qQualify the system. (a) Check whether the documentation listed under items 2 and 3 is complete and up-to-date, for example, does the revision of the existing user manual comply with the currently installed firmware and software revisions?

Title:Validation in Chemical Measurement
Author:Paul De Bièvre, Helmut Günzler
Publisher:Springer Science & Business Media - 2005-01-12


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