Objective evidence - meaning

Method validation is defined in the international standard, ISO/IEC 17025 as, the confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled. This means that a validated method, if used correctly, will produce results that will be suitable for the person making decisions based on them. This requires a detailed understanding of why the results are required and the quality of the result needed, i.e. its uncertainty. This is what determines the values that have to be achieved for the performance parameters. Method validation is a planned set of experiments to determine these values. The method performance parameters that are typically studied during method validation are selectivity, precision, bias, linearity working range, limit of detection, limit of quantitation, calibration and ruggedness. The validation process is illustrated in Figure 4.2. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

Most research papers that describe and conduct specific experiments, interpret experimental data, and evaluate the objective results of others, are often scientific in the nature and the tone of their writing style. In other words, these papers focus more on the accumulation of objective evidence, the various means by which data was tested and interpreted, and finally, the analysis of these results. Usually, these papers, by the specific nature of their subject matter and disciplines, are more focused in their scope. They are also more likely to be dictated in topic matter by a particular professor, professional discipline, or company. Some very broad ideas for possible topics in this area might include ... 

In a farsighted move in 1989, the European Union laboratory IRMM started a series of interlaboratory comparisons to provide objective evidence for the degree of equivalence and the quality of chemical measurements by comparing a participant s measurement results with external certified reference values (IRMM 2006). At the time most proficiency testing schemes used consensus results for the mean and standard deviation to derive z scores. With the IMEP-1 analysis of lithium in serum, the world was alerted to the problem of lack of accuracy in analytical measurements. The data of the first IMEP-1 trial are replotted in figure 5.6 notice that the apparent outlier was the only laboratory to come close to the assigned value. 

The main requirement of the audit team is to collect objective evidence throughout the audit task by means of interviews with the staff, examination of documents, and observation of activities and conditions at the work or site. The following methods may be used as a guideline or as appropriate to your company s operations to achieve the audit aim ... 

The FDA is part of the system of medical practice prevalent in the United States of evidence-based medicine. This means that there is objective evidence that a given therapy works. Within the execution of a more liberal practice of medicine, if a trial has shown that a particular beta-blocker works against a placebo, then physicians have the right to substitute a drug in the same class. 

The standard requires laboratories to document their policies, systems, programs, procedures, and instructions to the extent necessary to meet the requirements of customers while ensuring the quality and traceability of measurements, meaning that the laboratory determines the degree of detail found in its documentation. The laboratory must also be able to demonstrate objective evidence that the degree of detail presented in its quality system documentation is generating the desired and required outcome. Documentation must be available in a repeatable form and will normally be in either written or electronic form. 

Records — Documents which furnish objective evidence of the quality of items or services and of activities affecting quality, by means of which it may be determined whether the specified requirements are satisfied. 

Objective evidence Information that can be proved true, based on facts obtained through observation, measurement, test or other means. 

When we consider the multivariate situation, it is again evident that the discriminating power of the combined variables will be good when the centroids of the two sets of objects are sufficiently distant from each other and when the clusters are tight or dense. In mathematical terms this means that the between-class variance is large compared with the within-class variances. 

In the range of linearity, Eq. (29) correctly represents the heat transfer within the calorimeter. It should be possible, then, by means of this equation to achieve the deconvolution of the thermogram, i.e., knowing g(l) (the thermogram) and the parameters in Eq. (29), to define f(t) (the input). This is evidently the final objective of the analysis of the calorimeter data, since the determination of the input f(t) not only yields the total amount of heat produced, but also defines completely the kinetics of the thermal phenomenon under investigation. 

The core of the Evidence theory lies in the combination of belief assignments. As already described, several belief combination rules exist, each of them corresponding to an interpretation of the conflict between bba. As a consequence, a rule should be first chosen according to the interpretation of conflict appropriate to the final objective. In addition, some mathematical considerations should be also accounted for. Indeed, only the Dempster s and Smets rules are associative. This means that for other combination rules e.g., Yager s or Dubois and Trade s rules), we have (i) either to perform a simultaneous combination of all available bba or (ii) to determine the sequence of combinations appropriate to the final objective. The first choice is satisfactory since it does not need to perform any assumption on the combination order. However, it implies to compute a great number of intersections of focal elements and is thus difficult to apply for more than seven bba (due to the computation time required). 

Example 2 - Resource inputs and customer profitability. Firms invest resources in a customer relationship with the objective of earning a return on that investment. Consistent with this goal, Shapiro, Rangan, Moriarty, and Ross (1987) develop the price versus cost-to-serve (which includes pre-sale, order-related, distribution, and postsale service costs) framework, which links vendor investments to the returns from each customer relationship. This relationship, however, is not a simple one efforts to find a strong correlation between vendor investments in a relationship (as measured by cost-to-serve) and returns (i.e. price paid by the customer) typically fail. Shapiro, Rangan, Moriarty, and Ross (1987) interpret this as evidence that high income does not necessarily mean high cost-to-serve. And nor does low income necessarily mean low cost-to-serve. 

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