Full Description
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.
Contents
Bioanalytical method validation and its implications for forensic and clinical toxicology — A review.- Validation of a computer program for atomic absorption analysis.- Instrumental validation in capillary electrophoresis and checkpoints for method validation.- Qualification and validation of software and computer systems in laboratories.- Clinical reference materials for the validation of the performance of photometric systems used for clinical analyses.- Measurement uncertainty and its implications for collaborative study method validation and method performance parameters.- Qualification and validation of software and computer systems in laboratories.- Qualification and validation of software and computer systems in laboratories.- Qualification and validation of software and computer systems in laboratories.- Analytical validation in practice at a quality control laboratory in the Japanese pharmaceutical industry.- Validation of the uncertainty evaluation for the determination of metals in solid samples by atomic spectrometry.- Validation requirements for chemical methods in quantitative analysis — horses for courses?.- Validation criteria for developing ion-selective membrane electrodes for analysis of pharmaceuticals.- Is the estimation of measurement uncertainty a viable alternative to validation?.- Validation of an HPLC method for the determination of p-dichlorobenzene and naphthalene in mothrepellents.- The evaluation of measurement uncertainty from method validation studies.- The evaluation of measurement uncertainty from method validation studies.- Automated ion-selective measurement of lithium in serum. A practical approach to result-level verification in a two-way method validation.- Determination of hydrocarbons in water — interlaboratory methodvalidation before routine monitoring.- Interlaboratory quality audit program for potable water — assessment of method validation done on inductively coupled plasma atomic emission spectrometer (ICP-AES).- A need for clearer terminology and guidance in the role of reference materials in method development and validation.- Validation of salt spray corrosion test.- Method validation and reference materials.- Method validation of modern analytical techniques.- Validation of test methods.- Marketing Valid Analytical Measurement.- Analytical procedure in terms of measurement (quality) assurance.- Flexibilization of the scope of accreditation: an important asset for food and water microbiology laboratories.- Different approaches to legal requirements on validation of test methods for official control of foodstuffs and of veterinary drug residues and element contaminants in the EC.- Methods validation: AOAC's three validation systems.- Observing validation, uncertainty determination and traceability in developing Nordtest test methods.
