Data standardization, purpose

Description of process/environment Quality-related critical parameters Purpose and objectives of the system Major benefits of the system Special requirements Specific training needs System operating strategy Related GMP compliance/regulations Physical and logical boundaries System GMP risk assessment System validation rationale Life-cycle documentation Assumptions and prerequisites Limitations and exclusions Quality-related critical parameters/data Standard operating procedures System requirement specification Supplier and system history... 

For a well-established set of data, a frequently used set of control limits is 3 standard deviations. Thus, these limits can be used to determine whether the conditions under which the original data were taken have changed. Since the limits of three standard deviations on either side of the mean include 99.7% of the area under the normal curve, it is very unlikely that a reading outside these limits is due to the conditions producing the criterion set of data. The purpose of this technique is to separate the purely chance fluctuations from other causes of variation. For example, if a long series of observations of an environmental measurement yield a mean of 50 and a standard deviation of 10, then control limits can be set up as 50... 

Before initial delivery, each waste must be examined as to its relevant physical and chemical data. The purpose of this analysis is to make certain that the emission limits as well as occupational health and safety and fire-protection standards are not violated upon combustion. The results of this investigation make it possible to classify wastes, that is, to group them with respect to the combustion process and thus achieve optimal furnace conditions. 

Determine the equilibrium composition that is achieved at 300 bar and 700 K when the initial mole ratio of hydrogen to carbon monoxide is 2. You may use standard enthalpy and Gibbs free energy of formation data. For purposes of this problem you should not neglect the variation of the standard heat of reaction with temperature. You may assume ideal solution behavior but not ideal gas behavior. You may also use a generalized fugacity coefficient chart based on the principle of corresponding states as well as the heat capacity data listed below. 

The Standard Industrial Classification is an example of the use of numerical classification applied to non-numeric data. Its purpose is to classify numerically the variety of manufacturing and service industries making up the... 

In the first case, mechanical deformation is part of the sample preparation, where the sample is formed by testing used to obtain mechanical data. The purpose of conducting microscopy on the fractured sample is normally to determine the mode and propagation of failure and to correlate the mechanical data and sample microstructure. SEM of the fracture surfaces provides these observations for comparison with standards of similar materials [355]. The fracture could simply be used to provide access to an internal surface of the polymer for microstructural investigation. In this case, it must be remembered that the fracture surface is not a random section through the material, but one where the fracture required the least energy. 

Raw data must be analyzed and transformed into a format useful for specific purposes. Summary tables, graphs, and geographic distributions are some of the formats used for data display. Air quality information often consists of a large body of data collected at a variety of locations and over different seasons. Table 15-3 shows the tabular format used by the California Air Resources Board to reduce ozone hourly measurements to a format which shows information about compliance with air quality standards (6). The format has location, maximum values, annual means, and number of occurrences of hourly values above a given concentration as a function of the month of the year. One can quickly determine which areas are violating a standard, at what time of the year elevated concentrations are occurring, and the number of good data points collected. 

To aid in solute identification, a standard substance is usually added to a mixture and the separation ratio of the solutes of interest to the standard is used for identification purposes. In practice, separation ratios are calculated as the ratio of the distances in centimeters between the dead point and the maximum of each peak. If the flow rate is sufficiently constant and data processing is employed, then the corresponding retention times can be used. 

The standard requires that any obsolete document retained for legal and/or knowledge preservation purposes are suitably identified. Note that this requirement only applies to documents and not data. 

The heal of reaction (see Section 4.4) is defined as tlie enthalpy change of a system undergoing chemical reaction. If the retictants and products are at tlie same temperature and in their standard states, tlie heat of reaction is temied tlie standard lieat of reaction. For engineering purposes, the standard state of a chemical may be taken as tlie pure chemical at I atm pressure. Heat of reaction data for many reactions is available in tlie literature. ... 

Manufacturers will publish rating and application data for their products, based on standard test conditions and for the more usual range of uses. They cannot be expected to have accurate figures for every possible combination of conditions for an individual purpose, although most will produce estimates if asked. 

---