Verification activities - meaning

Definition of the verification activities that are to be performed to qualify or validate the design and those which need to be performed on every product in production as a means of ensuring that the qualified design standard has been maintained. 

Do provide a means of tracing the results of verification activities to the characteristics specified in the product specification. 

Any activity which affects the determination of product or service features and characteristics, their specification, achievement, or verification, or means to plan organize, control, assure, or improve them. 

While it is not essential that the verification check be performed by a supervisor, it is essential that production personnel be absolutely clear regarding FDA s expectations with respect to verification activities. The FDA expects that a verification of calculation and weighing steps be performed concurrently. Additionally, verification does not simply mean initialing the box it requires a review of the work performed for accuracy and completeness. Operators should be made aware of this during GMP training as well as training specific to the batch record. 

The results of a verification should be recorded to demonstrate that all prepared aspects have been covered. It should be clearly indicated which results met expectations and which did not (anomalies). All anomahes revealed by the various verification activities and analyses should be recorded and investigated. Records of all such anomalies should be maintained, including evidence of the means by which they were resolved. Where it is determined that a change is required to the documentation and source code, the procedures for changes described in Section 4 should be applied. 

Period of Inspection , for the purposes of Article IX, means the period of time from provision of access to the inspection team to the inspection site until its departure from the inspection site, exclusive of time spent on briefings before and after the verification activities. Period of Inspection , for the purposes of Articles IV, V and VI, means the period of time from arrival of the inspection team at the inspection site until its departure from the inspection site, exclusive of time spent on briefings before and after the verification activities. Point of Entry / Point of Exit means a location designated for the in-country arrival of inspection teams for inspections pursuant to this Convention or for their departure after completion of their mission. 

Model based developed is a heavily discussed topic in automotive industry. Most frequentiy this term means the automated code generation. However, simulations and automated checker functions instead of manual reviews are used more and more in context of functional safety especially for verification activities. Since for the verification we need to state the subject of the verification in an abstracted form, it is recommended, to let a model develop and mature alongside the product development. Whether the aim is to really create a complete model, which reflects the entire product in its integration environment, or the models should be adjusted for their purpose or even developed independently, depends on various factors. It is important however, that the models, which are used in development, are also considered in the context of project planning. The question is Which parts of the necessary activities can be automated and what purpose does the model serve . 

Finally, it is not appropriate to derive thermodynamic properties of solid solutions from experimental distribution coefficients unless it can be shown independently that equilibrium has been established. One possible exception applies to trace substitution where the assumptions of stoichiometric saturation and unit activity for the predominant component allow close approximation of equilibrium behavior for the trace components (9). The method of Thorstenson and Plummer (10) based on the compositional dependence of the equilibrium constant, as used in this study, is well suited to testing equilibrium for all solid solution compositions. However, because equilibrium has not been found, the thermodynamic properties of the KCl-KBr solid solutions remain provisional until the observed compositional dependence of the equilibrium constant can be verified. One means of verification is the demonstration that recrystallization in the KCl-KBr-H20 system occurs at stoichiometric saturation. 

The infancy of these first-principles methods as applied to periodic zeolite lattices means that further detailed work is necessary, particularly in the area of verification of the ability of the pseudopotential to reproduce dynamic as well as static structural properties. However, the results found with these methods demonstrate that the debate concerning the modeling of the activation of methanol within a zeolite is far from concluded. The proton transfer to methanol as a reaction in its own right is, however, of relatively little interest. It does not govern the pathway or energetics of reactions such as dehydration to give dimethyl ether (DME). These are governed instead by the individual transition states that lead to the products, as we discuss in the next section. 

For DQ (also referred to as enhanced design review) this means review of documented activities throughout the supplier s design, development, and build phases and can include FAT. This is followed by verification and testing of the computer system in its operating environment, under IQ, OQ, and PQ (see Fig. 2). 

As a final point to this section on inspections, it should be kept in mind that - as it is the case for any other operative procedures covered by the GLP Principles - the Quality Assurance Programme of inspections (and audits) should be subject to management verification. Management has to assure that the Quality Assurance responsibility is being performed in accordance with these Principles of Good Laboratory Practice which means that the Quality Assurance has to provide management with periodic reports on its activities, not only for single studies as already detailed above, but for the totality of its... 

A.2. Before the construction of a nuclear facility is begun, the regulatory body should monitor as appropriate, by means of its inspection programme, site preparation activities undertaken by the operator, including verification of site characteristics and authorized excavation and earthwork. 

In relation to state safely management, the internal control provides an important input and basis for state safety eontrol (4) in that reports and the like flowing from the industry s own eontrol activities in practice quantitatively eonstitute the most eentral input - more eentral than supervision and verification carried out directly by state inspectors. This means that the quality of the internal control and its output have to be secured. Therefore, the internal control also constitutes a separate object of state control in order to ensure that it can serve the intended purpose. The internal control is made both a basis and an object for state safety control. 

SP 131 describes Pauling s 1933 discovery and verification of the superoxide free radical, which now, 67 years later—has become of much interest as an active agent in oxidative damage to tissues and in the aging process. The control of this substance in living organisms, by means of the superoxide dismutase enzyme that catalyzes its decomposition, is an example of a potential task of orthomolecular medicine (see below). 

International inspectors means aU individuals designated by the Organisation according to the procedures as set forth in Part It, Section A of the Verification Annex to carry out activities to verify comphance with obhgations imder the Convention, including its declaration requirements or to assist carrying out such activities. ... 

Explanatory note Under this definition, contributions means (a) amounts assessed on States Parties under the provisions of Artiele VIII of the Convention, and (b) payments by States Parties of verification costs based on invoices issued by the Seeretariat subsequent to the verifieation activities undertaken under the provisions of Articles IV and V of the Convention. 

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