Documenting System Limitations

When the system is completed, the system limitations need to be identified and documented. Some of the identification will, of course, be done throughout the 

Limitations should be included in level 1 of the intent specification, because they properly belong in the customer view of the system and will affect both acceptance and certification. 

Some limitations may be related to the basic functional requirements, such as 

L4 TCAS does not currently indicate horizontal escape maneuvers and therefore does not (and is not intended to) increase horizontal separation. 

Limitations may also relate to environment assumptions. For example  

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Common to all encapsulation methods is the provision for the passage of reagents and products through or past the walls of the compartment. In zeolites and mesoporous materials, this is enabled by their open porous structure. It is not surprising, then, that porous silica has been used as a material for encapsulation processes, which has already been seen in LbL methods [43], Moreover, ship-in-a-bottle approaches have been well documented, whereby the encapsulation of individual molecules, molecular clusters, and small metal particles is achieved within zeolites [67]. There is a wealth of literature on the immobilization of catalysts on silica or other inorganic materials [68-72], but this is beyond the scope of this chapter. However, these methods potentially provide another method to avoid a situation where one catalyst interferes with another, or to allow the use of a catalyst in a system limited by the reaction conditions. For example, the increased stability of a catalyst may allow a reaction to run at a desired higher temperature, or allow for the use of an otherwise insoluble catalyst [73]. 

The acquisition of substance data and the introduction of harmonised instra-ments for evaluation, conununication, documentation and limitation of application risks in the European market can only function at an extra-corporate level. In so doing, the following should be observed, if such solutions are in line with practice, their development catmot be left solely up to official bodies. If the costs are to be minimised, the companies have to develop standards jointly, which can however also entail the exchange of information that is relevant to a potential competitor. Thus, companies have to demonstrate courage, if efficient system solutions are to be developed at an extra-corporate level. 

The recommendations embodied in this document are concerned with the terminology relating to the structure of crystalline polymers and the process of macromolecular crystallization. The document is limited to systems exhibiting crystallinity in the classical sense of three-dimensionally periodic regularity. The recommendations deal primarily with crystal structures that are comprised of essentially rectilinear, parallel-packed polymer chains, and secondarily, with those composed of so-called globular macromolecules. Since the latter are biological in nature, they are not covered in detail here. In general, macromolecular systems with mesophases are also omitted, but crystalline polymers with conformational disorder are included. 

In practice, PQ can mean system suitability testing, where critical key system performance characteristics are measured and compared with documented, preset limits. For example, a well-characterized standard can be injected five or six times and the standard deviation of amounts are then compared with a predefined limit. If the limit of detection and/or quantitation are critical, the lamp s intensity profile or the baseline noise should be tested. Following are the steps recommended for (system suitability) PQ tests. 

In practice, we have utilized it for the analysis of molecular systems comprised of 3 to 5 fused benzene rings. Our discussion in this document is limited to the following compounds phenanthrene, anthracene, fluoranthene, pyrene, benz(a)anthracene, chrysene, benzo(e)pyrene, benzo(a)pyrene, and dibenz(a,h)anthracene. The structures for these compounds are presented in Table I. It is important to note that the method has also been adapted to the determination of several other PAH compounds (e.g., benzo(c)phenanthrene, perylene, 3-methylcholanthrene, carbazole, 7H-dibenzo(c,g)carbazole, and indeno(l,2,3-cd)pyrene). 

Align security measures for the computer system with your corporation s Information Asset Protection Policies (lAPP) and coordinate with the building and/or plant security plans. For some systems, strict compliance with specific security requirements mentioned in the lAPP may not be possible given proprietary system limitations. Examples may include unique user identification codes, specified lengths for user identification codes and passwords, or inactivity time-outs. Use a deviation change process to document and justify these situations. 

Details on system screen designs, report layouts, data dictionary with data flow diagram, system configurations, system security, file design, system limitations and memory requirements are laid out by system developers and are usually formally inspected with members of the development team. Major outputs of this phase are the internal design documents and prototypes. The design documents are based on the ERS and can be used as a source for the technical support documentation. 

A great deal has been written about manual documentation systems in the pharmacy literature, both in clinical practice and in education, but these systems tend to be individualized applications in which the transfer of data to other providers is nonexistent or quite limited. " Many documentation systems in pharmacy focus on the generation of reports for workload analysis or accreditation purposes. Unfortunately, the information gathered and analyzed in such... 

At this point in development, the safety requirements and constraints are documented and traced to the design features used to implement them. A hazard log contains the hazard information (or links to it) generated during the development process and the results of the hazard analysis performed. The log will contain embedded links to the resolution of each hazard, such as functional requirements, design constraints, system design features, operational procedures, and system limitations. The information documented should be easy to collect into a form that can be used for the final safety assessment and certification of the system. 

Teijin Limited, 2013. Closed-Loop Recycling System ECO CIRCLE [WWW Document]. Teijin Limited. Available at http //www.teijin.com/solutions/ecocircle/(accessed 10.08.13). 

SCFs are an environmentally friendly alternative to organic solvents as media for biocatalysis. A key feature of biocatalysis in SCFs is the tunability of the medium [75]. Enzymatic activity in SCFs has been proven and well documented [76]. Limiting factors, which may affect enzymatic activity in supercritical solvent systems, have been identified and are well characterized. A major limitation to the broader use of SCFs is their inability to dissolve a wide range of hydrophilic and ionic compounds, which greatly impedes their ability to carry out biolransformation with polar substrates. The interest in water-in-SCF microemulsion as reaction media stems from the fact that in such systems high concentrations of both polar and apolar molecules can be dissolved within the dispersed aqueous and continuous SCF phases, respectively. 

A six-step methodology is suggested for the barrier evaluation. It describes the process for collection, systemization, visualization and evaluation of safety information related to rig move operations. The main activities were the document reviews and meetings with operational personnel of the company under study. Clarification of the system limits and a correct interpretation of rig move operations were important initial activities to ensure an appropriate basis for the barrier evaluation. Main input to the evaluation was requirements, procedures and reports covering relevant incidents and accidents as well as the operational knowledge of the involved experts. 

Information can be extracted from these to generate specific new documents, or it may sometimes, in the case of a small project, be simpler to annotate existing documents. The PStlDs can be marked up to define functional system limits. If this approach is decided, it is very important to recognize from the outset the very considerable amount of time and effort required. 

CHARMM is the first program system published which deserves the designation "molecular mechanics , in the sense that it treats static, kinematic and dynamic properties. All other programs available are much more limited in scope. A few warnings for the uninitiated are in place The more complicated a system is, and here I mean only modern well-structured and well-documented systems, the more attention is required to maintain and operate it, and that cannot be left solely to the computer people. Also, know-how does not come by itself or on a tape. For many prospective applications, potential energy function parameters, or even the functions themselves, are lacking, just as for the simpler systems. Parameters must be found by trial and error, as is usual, or, preferably, by optimisation, which cannot be done in CHARMM a program of the consistent force field family is necessary. 

A number of methods have been developed to introduce context to on-line databases, enabling searches to be refined to minimized false retrieval. One of the earliest techniques is proximity searching, in which two words are required to be adjacent, or within a limited distance from each other in text. The assignment of roles to chemical substances is a method of precoordinating concepts. A substance can be identified as a reactant, as a product, and in some systems in a number of additional roles. For example, by searching for documents in which formaldehyde is a product, documents in which it is a reactant, or in which it undergoes no reaction, are thus eliminated. 

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