Qualification meaning

No testing of the [computer] system after installation at the operating site. Operating sites are part of the overall system and lack of their qualification means the system validation is incomplete. [FDA 483]... 

Snccessfnl Operational Qualification means that cut-over of the system into live operation can be considered. Other issnes affecting cut-over are whether all procedures and software have been... 

In version 1, the definition is qualified by the statement In the last case of this definition, let logically equivalent mean equivalent according to the rules of classical two-valued propositional calculus. This qualification means, in effect, that Definition 1 defines the system of classical, two-valued logic. The definition is employed in the following theorem ... 

Qualification, verification and validation of models Qualification refers to the development of the conceptual model. Qualification means that the model needs to be interpreted with a sufficient confidence level. Knowledge incorporated into the model must be re-used without loss or bad interpretation by actors coming from different domains and involved in other decision processes in the enterprise (Chapurlat and Braesch, 2008, 715). Verification checks that the code does what was intended and that the model represents reality. The verification and validation (V V) definitions used in this report are adopted from the 1998 American Institute of Aeronautics and Astronautics (AlAA) Guide (2) "Verification is the process of determining that a model implementation accurately represents the developer s conceptual description of the model and the solution to the model. Validation is the process of determining the degree to which a model is an accurate representation of the real-world from the perspective of the intended uses of the model". Although V V are processes that collect evidence of a model s correctness or accuracy for specific scenarios, V V cannot prove that a model is correct and accurate for all possible conditions and applications. It can provide evidence that a model is sufficiently accurate. Therefore, the V V process is completed when sufficiency is reached. 

The term approval can be taken to mean certification or qualification, the difference being that certification is performed each time the equipment is repaired and qualification only when the equipment is introduced into service. The standard only refers to the term qualification in connection with special processes, but this clause does not distinguish between special and ordinary processes and equipment. However, there are two levels of approval that apply to processes and equipment initial qualification approval and periodic setting-up approval. 

To limit the potential for deficiencies to escape detection before the product is released, special processes should be documented in the form of procedures and specifications that will ensure the suitability of all equipment, personnel, and facilities, and prevent varying conditions, activities, or operations. Qualification in the context of special processes means that you need to conduct a thorough assessment of the processes to determine their capability to maintain or detect the conditions needed to produce conforming product consistently. The limits of capability need to be determined and the processes only applied within these limits. In qualifying the processes you need to qualify the personnel using them by training and examination as well as the materials, equipment, and facilities employed. It is the combination of personnel, materials, equipment, and facilities which ensure qualified processes. 

Section 1.9 showed that as long as an oxide layer remains adherent and continuous it can be expected to increase in thickness in conformity with one of a number of possible rate laws. This qualification of continuity is most important the direct access of oxidant to the metal by way of pores and cracks inevitably means an increase in oxidation rate, and often in a manner in which the lower rate is not regained. In common with other phase change reactions the volume of the solid phase alters during the course of oxidation it is the manner in which this change is accommodated which frequently determines whether the oxide will develop discontinuities. It is found, for example, that oxidation behaviour depends not only on time and temperature but also on specimen geometry, oxide strength and plasticity or even on specific environmental interactions such as volatilisation or dissolution. 

The ideal variable to measure is one that can be monitored easily, inexpensively, quickly, and accurately. The variables that usually meet these qualifications are pressure, temperature, level, voltage, speed, and weight. When possible the values of other variables are obtained from measurements of these variables. For example, the flow rate of a stream is often determined by measuring the pressure difference across a constriction in a pipeline. However, the correlation between pressure drop and flow is also affected by changes in fluid density, pressure, and composition. If a more accurate measurement is desired the temperature, pressure, and composition may also be measured and a correction applied to the value obtained solely from the pressure difference. To do this would require the addition of an analog or digital computer to control scheme, as well as additional sensing devices. This would mean a considerable increase in cost and complexity, which is unwarranted unless the increase in accuracy is demanded. 

The responsibilities of personnel and the laboratory s management structure must be clearly defined, by means of organizational charts, job descriptions and curriculum vitae for the personnel who are carrying out the study. There must also be up-to-date records of qualifications and of the training that the staff have received, including any records necessary to show their competence to carry out their work. 

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... 

For some quants staff is required with different qualifications and fractional numbers (multiple resources). One staff qualification for the setup and one qualification for the production for each quant are taken into account. For certain resources a shift model and also lockup intervals were defined. These constraints may force quants to be enlarged or lengthened over a shift break or lockup interval. This means that within the setup and production intervals of a quant there can... 

A policy statement alone is worth very little. Management must provide a sustained commitment of resources for an ongoing program. The most important resources are the right people having the background, qualifications, experience and commitment needed to safely operate and maintain the facility. This includes the technical expertise to understand chemical reactivity hazards and their control and the means to maintain the needed knowledge over time. 

In this connection, the members of this Section could do a service to the other Sections by making clearer the real meaning of some of the physical concepts and physical constants involved in geophysical problems. For instance, much confusion has been caused by the fact that there is more than one kind of rigidity . The geologist to whom the statement that the earth has the rigidity of steel is rather vague may take temporary comfort from the fact that the statement also needs much qualification and explanation to the physicist. ... 

Any quotation chosen by a company for use in promotional material must comply with the requirements of the Code itself. For example, to quote from a paper which stated that a certain medicine was safe and effective would not be acceptable even if it was an accurate reflection of the meaning of the author of the paper, as it is prohibited under Clause 7.9 of the Code to state without qualification in promotional material that a medicine is safe. 

Classical MALDI-MS requires that the material should be soluble in a suitable solvent. A suitable solvent means a solvent that is sufficiently volatile to allow it to be evaporated prior to the procedure. Further, such a solvent should dissolve both the polymer and the matrix material. Finally, an ideal solvent will allow a decent level of polymer solubility, preferably a solubility of several percentage and greater. For most synthetic polymers, these qualifications are only approximately attained. Thus, traditional MALDI-MS has not achieved its possible position as a general use modern characterization tool for synthetic polymers. By comparison, MALDI-MS is extremely useful for many biopolymers where the polymers are soluble in water. It is also useful in the identification of synthetic polymers, such as PEO where the solubility requirements are fulfilled. Thus, for PEO we have determined the molecular weight distribution of a series of compounds with the separations in ion fragment mass 44 Da corresponding to CH2-CH2 units. 

This expression requires some qualification. It must be made clear that yield , for this example, means yield of C with respect to A. Also, it must be recognised that the concentration of a reaction species may change with time or with location within a reactor. Consequently, the relative yield may also change. The symbol (j> will be used to denote instantaneous relative yield (for a very small element of space or time) and will be used to denote the overall yield for the whole reactor during its operational period. For the reactions (95) and (96) we have... 

In general, bias refers to a tendency for parameter estimates to deviate systematically from the true parameter value, based on some measure of the central tendency of the sampling distribution. In other words, bias is imperfect accuracy. In statistics, what is most often meant is mean-unbiasedness. In this sense, an estimator is unbiased (UB) if the average value of estimates (averaging over the sampling distribution) is equal to the true value of the parameter. For example, the mean value of the sample mean (over the sampling distribution of the sample mean) equals the mean for the population. This chapter adheres to the statistical convention of using the term bias (without qualification) to mean mean-unbiasedness. 

---