Functional specification

Differentiation of Eq. (8) with respect to the position of a molecule gives a hierarchy of integro-differential equations, each of which relates a distribution function to the next higher order distribution function. Specifically,... 

Computer/control system experts who know how to implement an actual control scheme after a functional specification has been developed in cooperation with process and production experts. 

Built-in functional specific recognition and binding, e.g., antigen binding by antibodies or hybridization of nucleic acids ... 

In Eq. (4.23d), N is the number density of molecules, cross section for production of any primary species x at electron energy E having an energetic threshold Ix for its production, and N/T) is the total number of such species formed by the complete absorption of an electron of kinetic energy T. In this sense, y can be thought of as a distribution function. Specifically, if x refers to ionization, Ix is simply the ionization potential I, Ox is the ionization cross section a, and N = n., the total number of ionizations. 

Consistent with this proposition, variants have been reported for all the other systems but not for [Het-s]. (4) [Het-s] is a gain-of-function prion and the only prion currently on record to have an evolved cellular function, specifically, a key role in heterokaryon incompatibility. How this function is accomplished is unclear but it seems possible that the prion filaments may constitute some kind of platform on which allelic comparison can be performed. 

We will merely call attention here to the tremendous inter-individual human variability which exists in the anatomy of the endocrine glands. This variability is foreshadowed by the data already given with respect to rabbits and pigeons (pp. 2021). Since a separate chapter is devoted to these glands and their functioning, specific anatomical information with respect to the specific glands will be presented there. It is possible that these anatomical variations are more important from the standpoint of health and well-being than any we have so far discussed. 

A short stability curve is not necessarily a reason to reject a particular column. If the unique selectivity of a given column is essential for achieving a particular analytical separation, it can be used so long as its performance is validated to persist for a specified number of runs and a column log is maintained to document that its usage is limited accordingly. Periodic analyses to document that it is still within functional specification may also be prudent. The point is to ensure that assay performance does not fall victim to an undetected source of progressive variation. 

As indicated, a progressively larger portion of activities in a clinical trial matrix is controlled by function-specific software, provided by IT vendors, CROs, or sponsors. This may be problemahc in study sites that execute multiple studies for different sponsors simultaneously, all having different SOPs, data collection procedures and payment policies. Standardized site-specific software is being developed and refined to accommodate this problem, but currently busy study sites can find this accommodation challenging. 

One point that arises from study of these E2-E3 structures, is that there is a degree of specificity in their physical interactions. The biochemical data extends the idea of physical specificity in E2-E3 interactions to functional specificity. An example of this is the Brcal-Bardl heterodimer, which interacts physically with UbcH7 and UbcHSC, but is only active with UbcHSC. There appear to be two consequences of E2 specificity variability in the strength of a particular E3 response and variability in the type of ubiquitin modification. 

User requirement specifications (URS) for the computerized system are provided by the pharmaceutical firm to the computer systems vendor. The vendor generates functional and design specifications as a basis for designing and coding software for the computerized system. The system is then built, together with all the interfaces to the hardware, and tested by the vendor. After installation of the computerized system, IQ, OQ, and PQ are performed at the pharmaceutical facility to verify that the system is able to meet the URS and design and functional specifications. 

Confirm and document that system is operating according to vendor s functional specifications ( 0)... 

Next, one should develop the functional specifications for a system. The functional specifications document should establish the HPLC system s actual capabilities as they apply to the full scope of the URS. Some of the more specific URS requirements may be included in the functional specifications as well. This document is often developed with significant vendor interaction and input. 

Operational Qualification—The OQ is the protocol that verifies that the operation of the system meets the written and pre-approved performance and functional specifications established by the vendor within its required operating range. 

The LC control software, either stand-alone or as part of an overall data-handling system, should be tested by means of a separate OQ protocol. This protocol only needs to address the communica-tions/control integrity of the hardware (e.g., setting up a run/sequence with the proper instrument parameters, the ability to start and stop the pump, etc.). It should cover all the required instrument control functions listed as part of the protocol s functional specifications. It does not need to include specific hardware performance testing, such as linearity or flow rate. The latter tests are performed separately, as part of the individual hardware validation described below. 

The IQ is typically followed in close succession by the OQ protocol. The OQ confirms and documents that an instrument operates in accordance with the vendor s functional specifications. Again, similar to that for the IQ, the OQ protocol is often partly, if not totally, developed by the vendor of the instrument. In some laboratories, the internal calibration tests may be incorporated as part of the OQ protocol. In most cases the protocol is typically carried out by a vendor s qualified service engineer. Since the same service engineer often performs both the IQ and the OQ, the IQ and PQ are often combined as part of an overall IQ/OQ protocol. 

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