How to Validate

Schutz CN, Warshel A (2001) What are the dielectric constants of proteins and how to validate electrostatic models Proteins 44 400-417. 

Wood, R. (1999), How to validate analytical methods, Trends Anal. Chem., 18, 624-632. 

Validation in quality systems includes establishment of procedures on how to qualify the equipment and machinery, how to verify the design of products, how to verify the process designed, how to verify the achievement of production procedures, how to validate the process developed, and how to validate the methods for measurement and assay. Validation also requires verification of specifications or acceptance criteria of in-process parameters relating to both raw materials and intermediate (in-process product) and finished products, and verification of acceptance criteria for in-process parameters relating to operating conditions of machinery and equipment. Further, when the medical device is assembled at the user s site, validation includes establishing procedures of how to verify assembly. 

In this connection, a difficult problem is how to validate such models to analyze their reliability. The absence of adequate validation means that the results of numerical modeling using integral models can be considered only as possible scenarios—but not forecasts. 

Developing the validation protocol is a crucial step in the validation process. It is the culmination of the regulatory and technical accomplishments to this point in the development of the method. The protocol must define which validation parameters are needed and the specific experiments necessary to demonstrate the validity of the analytical method. The protocol must contain all of the acceptance criteria for each of the relevant validation parameters. Additionally, the protocol must define the number of replicates, the reporting format, and the number of significant figures. In short, the validation protocol instructs the analyst on how to validate the analytical method. 

How to validate and docnment software developed in the nser s own laboratory... 

Before discussing how to validate a chromatography data system, it is important to understand the regulatory requirements and their interpretation. The responsibility for the validation rests with the system or business process owner, but from experience it is seen that most do not understand fully the regulations they work under or the risk of mitigation strategies that need to be undertaken when validating a CDS. 

Users of computer systems may develop software on their own either as a stand-alone package, such as a software for specific statistics, or as an add on to the standard software. This software should be validated and programmers should get ideas and advice on how to validate. 

How to validate international, national and individual laboratory methods... 

How to validate models Agreement is needed on what level of validation is needed. Should the overall outputs be validated, or is it more important to validate individual processes. Is it enough to demonstrate that the model is conservative, or should it reproduce real population dynamics accurately ... 

HOW TO VALIDATE CHEMICAL ABSTRACTS SERVICE REGISTRY NUMBERS... 

While Theorem 4 is a starting point towards a method for demonstrating uniqueness, it does not actually explain how to validate that a best reply mapping is a contraction. Suppose we have a game with n players each endowed... 

With both 2-D and 3-D descriptors, the thorny issue of how to validate descriptors is still an open question. It is clear that we would like to have... 

Note that selecting a proper physical property method is extremely important for obtaining reliable simulation results of a process flowsheet. Aspen Physical Property System gives the recommended classes of property methods for different applications. The phase equilibrium behavior predicted by the selected physical property method should be compared to experimental data for validation purpose. The experimental data that can typically be found in literamre includes the Txy and yx data binary and ternary LLE data VLLE data and azeotropic information. For details of how to validate the prediction of the selected physical property method, please refer to Chapter 2. 

How to validate a proposed human dependability model for space application ... 

The important questions to be addressed are the following How to detect interactions of multiples aspects at a shared join point How to specify the expected behavior How to validate composition ... 

This chapter serves as a guide to model atmospheric distillation section of the crude distillation unit. We provide relevant process, operational and modeling details to model the atmospheric column. We also discuss methods to estimate missing data for model development We provide step-by-step instructions to model a particular column in Aspen HYSYS. We discuss how to validate the model predictions with plant data and how to use the model to perform industrially useful case studies. 

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