Software In-House

Many developers of software for finite-element analysis (18) provide drafting of pipelines and associated flow analysis. These companies include Algor, McAuto, MacNeal-Schwindler, and ElowDesign. In software, in-house developed pipe fittings are modularized and isometric views of the piping systems with three-dimensional detailing are now commonplace. 

One disadvantage of in-house development is that a large committment to development and support is required. Another is that if commercial software has been available for a while, other users have probably found most of the bugs, with in-house software, in-house users must be patient and supportive during the debugging process. 

Despite the market explosion of data management software, there are still situations which justify in-house development. When it is appropriate to develop software In-house, design philosophies such as those Implemented in the MARS system will help reduce the development and maintenance investment and enhance the effectiveness of the system. 

The NCBI does use a flat file approach to parse and retrieve the data in their databases and present it on the web. While the NCBI continutes to add databases, there are not as many databases available as some SRS servers, and hence it is difficult to find relationships that may exist between the data displayed and data in other databases. Since the NCBI present their data on their web site it is also not possible for other academic institutions or companies to bring the software in-house for integration of their proprietry data. 

Stmcture searching and display software are host-specific. The Softon Substmcture Search System (S4) was developed by the Beilstein Institute and Softon of Graefelfing Germany (50). It is a full stmcture and substmcture searching module. The S4 is used in-house by the Beilstein Institute and is operated by DIALOG. STN uses CAS ONLINE s messenger software for on-line stmcture searching of the Beilstein on-line database (51). 

Essential Elements for Developing In-house, Special-Purpose CAD Software... 

The use of color graphics is also an effective means for displaying chemical stmctures. This method is far better than typesetting the three-dimensional architecture of complex multimolecule assembly (112). For developing in-house CAD software programs, the three-dimensional, sohd-modeling capabiUties of SdverScreen can also be utilized either in monochrome or color for constmction of such stmctures (113). 

Hunt and Kulmala have solved the full turbulent fluid flow for the Aaberg system using the k-e turbulent model or a variation of it as described in Chapter 13— the solution algorithm SIMPLE, the QUICK scheme, etc. Both commercial software and in-house-developed codes have been employed, and all the investigators have produced very similar findings. 

If there is no restriction placed on the proposal by having to use the current in-house computer system, the choices of hard ware/software packages are numerous. The software must be user friendly, complementary to existing systems to avoid duplication of asset registering, etc., and have the facility to expand (i.e. have other programs (modules) that enable greater use be made of the information held within the system). The program should also be compatible with any in-house computer system where possible. 

The hardware should be dedicated to the maintenance department, as they then have access to the maintenance programs as and when necessary. Systems are implemented whereby the software is loaded onto the company in-house hardware, which can lead to periods when access is limited by other demands on computer time (e.g. accounts departments). The ideal situation would be for the maintenance department to have their own computer, with the back-up facility provided by the in-house computer, thereby ensuring that copy is held. 

Neither database generally offers the possibility of integrating into it the greater number of values and test data that may already be established by users or processors. These organizations have data for their own internal use, and their goal has been to integrate all these types of data sources. Such in-house databases are at present available under operating system BS 2000 and in conjunction with the database software known as Adabas. 

Data System development is an area which has recently seen tremendous growth. Instrument vendors pay increasing attention to their software in recognition of its vital role in the commercial success of their product. Manufacturers of data acquisition hardware are likewise working to bundle their hardware with attractive software. Software houses are offering some ambitious packages for data analysis applications. 

The first type are the Specific/Bundled Data Systems. These are written specifically for a particular application and are often bundled with the instrument by the manufacturer. One example is the DuPont Thermal Analysis Data System. The second type are the General CoHsercial data systems which provide a structure that can be configured for many applications. This category includes software like Labtech Notebook and Lotus 1-2-3. The third category are those which are developed In-house and may lie anywhere along the spectrum between specific and general in function. 

In-house Data Systems can provide an answer where no commercial alternatives are available or satisfactory. They offer complete control over what the software does and how works. In-house systCims also provide a familiar software environment when adapted for a number of applications. Perhaps surprisingly, the cost effectiveness of in-house systems can be superior to commercial systems when spread over a number of applications and installations. 

The minicomputer based system for Instrument automation at Glidden has been prevlousj.y reported (1). since that system predates the availability of low cost personal computers and data acquisition hardware, most of the hardware and software was designed and assembled in-house. ... 

Since we are a research center, many of our requirements are unique and evolving. Therefore, although we favor use of commercial specific/bundled systems where possible, we are more often than not funneled into the in-house option. The software system designed and written in-house and which is adapted for most of our applications is called MARS, an acronym for Management, Analysis, and Reporting System. 

A difficult balance to maintain is the tightrope between custom and general operation. For minimum development and maintenance, the software should be very generalized. However, from the user s perspective it must be fast and easy to use. These two poles often conflict. If the in-house software is too general, one may as well buy a general commercial package. Too specific and it loses cost effectiveness. The end product must be generalized yet customizable to the requirements of the application. 

Most e-Clinical software consists of integrated suites of applications that support the clinical research process, including various ways of data entry that include in-house data entry, remote data capture, batch data load, and scan forms. These suites enable customers to quickly and easily design studies, capture clinical data, and automate workflow. Some e-clinical software systems are also Internet based. 

Depending on the size of the CRO and the nature of the trial, the system may be acquired in one of the following ways (1) developed in-house by the organization s staff with off-the-shelf commercial software, (2) outsourced to outside contractors, (3) with open source/free software (OSS/FS), and (4) purchased from e-clinical proprietary vendors. 

Other factors include available resources in terms of money and manpower to develop the system in-house, outsource, or purchase from e-clinical proprietary vendors, reliability, flexibility, and security. Some coordinating centers have chosen OSS/FS over proprietary vendors based on the criteria of cost, reliability, flexibility, and security [38]. The rationale is that although both have service comparability, proprietary software licensing costs, both for initial purchases and annual licensing, are significant. 

Because of the complexity of computer hardware and software and because of the intricacy of a risk assessment, the FDA has to all intents and purposes adopted an indirect regulatory posture. Regulated companies are informally urged to conduct independent audits of Part 11 compliance, utilizing in-house or consultant expertise. The agency can then review the details of the audit report and the credentials for experience, expertise, and independence of the auditor. Follow-up investigation of speciflc points can then be laser-focused on specific areas of concern. 

GLP regulations require QA personnel to inspect/audit each study conducted, but the extent to which QA personnel are involved in software development and the val-idation/verification process varies from company to company. In some companies, there is little or no QA involvement in these processes, whereas in others QA personnel are involved. QA personnel can provide assistance in the area of vendor audits for purchased software or can conduct inspections of in-house software development to ensure that internal procedures are being followed. QA personnel, who conduct in-process inspections and review the resulting data and validation report for accuracy, could provide inspection support during the validation and verification process. During system development and validation, properly trained QA personnel can provide the regulatory advice needed to ensure that the system will meet government standards. QA personnel become more familiar with the system(s) that will be used when they are involved early in the validation process. 

At this point, the availability of a purchased product that fulfills the software/computer system design description should be researched. If a commercial product is not available, and the capabilities for software/computer system design are available in-house, the design phase can be initiated. 

International or in-house standards in combination with fundamental parameters software, lead to the same accuracy as conventional analysis using regression analysis of standards. Provided that accurate standards are available, the main factors that determine the accuracy of XRF are the matrix absorption correction and (in the case of EDXRF) the spectrum evaluation programme, i.e. correction for spectral overlap and background. 

Several companies have adapted these experimental analysis techniques to computer software, but have kept the programs in-house. Representatives of a few... 

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