Customized system

A variety of commercial instruments are available for PL measurements. These include spectrofluorometers intended primarily for use with liquids in a standard configuration, and simple filter-based systems for monitoring PL at a single wavelength. For use with opaque samples and surfaces, a few complete commercial systems are available or may be appropriately modified with special attachments, but due to the wide range of possible configuration requirements it is common to assemble a custom system from commercial optical components. 

A schematic of a PL system layout is shown in Figure 5. This optical system is very similar to that required for absorption, reflectance, modulated reflectance, and Raman scattering measurements. Many custom systems are designed to perform several of these techniques, simultaneously or with only small modifications. 

QA requires the efficient analysis of many samples to support routine production release and stability programs. Methods are typically established in the analytical development group. Efficiency and convenience issues, including the speed of media preparation and the relative convenience of data handling and documentation, are important here. While compliance is important in all aspects of the pharmaceutical industry, QA functions must approach compliance perfection. Depending upon the facility, the automated apparatus may be tailored to specific methods with fixed configurations. Dissolution methods may be routine enough that a custom system, optimized for productivity, may be justified. Compliance of USP and use of industry standard apparatus is important to maintain compatibility with other company laboratories or in the case contract laboratory services are required. 

Fully automated systems can be purchased off the shelf or fully customized. Customized systems offer exactly what the customer wants and needs, for example a system might be optimized for one high volume product. Off the shelf systems are available that are fully integrated systems with components designed by the provider. As with the semiautomated systems modular approaches are also available primarily through automation companies. Modular approaches allow the use of standard industry apparatus that the user already owns and uses (Fig. 5). 

In accordance with GAMP, there are different validation strategies depending on the categories of software the degree of validation increases from a general system to a custom system (see Exhibit 9.9). 

S. Ogoronikov and V. Petrunin, Processing of interlaced images in 4—lOMeV dual-energy customs system for material recognition, Phys. Rev. Spec. Top. - Accelerators and Beams, 5, 104701 (2002) 1-12. 

To a lesser degree a noncustomized package wiU provide greater confidence than a customized system, if for no other reason than the fact that the problems users find (and force fixes of) are more numerous and of a greater variety. When risks are not an issue, a more widely used system can result in a lower classification. 

The Laboratory Information Management System (LIMS) has achieved wide recognition as a powerful tool for increasing the productivity and quality of service of the analytical laboratory. Systems have been developed that range from inexpensive microcomputer based systems to half-million dollar or more large, minicomputer based systems. In addition, many firms have already developed or acquired custom systems tailored to their specific needs(1-8). 

A process scheme (Figure 4.87) consists of standardized surface-mount components and can be arranged on the screen to a customized system. The software also delivers a summary considering necessary seals and pipe fittings which can be used for ordering directly (Figure 4.88). 

Custom systems very expensive and can take years to obtain in adequate numbers Limited but appreciable data on chemical carcinogens and promoters... 

Autoencoders are a unique and specialized class of software. One must remember that coding is a means to an end. Data consistency is the desired result. For this reason, companies will use different dictionaries and methods to code adverse events and drugs. There is no standard other than the dictionaries used for the process. Autoencoders are usually custom systems developed by a company for its own use. Commercial autoencoders do exist, and they generally provide facilities to audit the coding and provide custom dictionaries based on the general dictionaries above. 

The URS should not delve into design detail that should be postponed to the Functional Specification. This may be difhcult when specifying bespoke or customized systems, as the design is often anticipated when developing the URS. It may also be tempting to include far too little detail in a URS when a COTS product solution is anticipated. 

System Flexibility. Standard SCF systems are available from a variety of manufacturers. The cost of a standard system is always less than a custom design. However, specific process circumstances may demand a custom system and operating costs are secondary considerations for parts that cannot be processed by other methods. 

There are many applications and systems that can be used to design and generate the CRFs. These range from word processing and desktop publishing packages to customized systems that facilitate the maintenance and use of a library of modules/forms and enforce standards. The CRF may also be in an electronic format rather than on paper, as in the case of remote data entry systems. 

To a lesser degree, a noncustomized package will provide greater confidence than a customized system, if for no other... 

The forerunners to the systems now called Laboratory Information Management Systems first appeared in the late 1960s as in-house software solutions. The intention was to help streamline the data flow from frequently performed laboratory tests and to transcribe the results to a centralized data repository. In the 1970s custom-built systems became available. These early custom systems were one-off solutions designed by independent systems development companies to run in specific laboratories. The complexity of these systems had increased to allow them to facilitate the transfer of large quantities of data in an electronic format from specific laboratory instruments. 

From R D to quality control, rheology measurements for each phase of the product development life cycle involve raw materials, premixes, solutions, dispersions, emulsions, and full formulations. Well-equipped laboratories with stress- and strain-controlled oscillatory/steady shear rheometers and viscometers can generally satisfy most characterization needs. When necessary, customized systems are designed to simulate specific user or process conditions. Rheology measurements are also coupled with optic, thermal, dielectric, and other analytical methods to further probe the internal microstucture of surfactant systems. New commercial and research developments are briefly discussed in the following sections. 

Very good technological understanding of the customers systems ( know more than the customer himself ). 

As throughput needs increase, add additional independent sample dilutors and assay robots. If needed, evaluate customized systems that may offer higher throughput, but be mindful of the difficulty in validating custom software in a GLP environment. 

One important consideration is the decision to go with popular off-the-shelf systems from well-established vendors, similar systems from smaller vendors, or custom systems. It is important to keep in mind some of the vendor selection criteria mentioned earlier in the chapter vendor support, vendor stability, and experience working with GLP customers. Smaller vendors or custom software are not necessarily bad, but they can have more software bugs since they have fewer customers using the software and reporting problems. Given the need for validation and change control, the system with the fewest problems is often the best investment. 

MRP 11/ERP systems enable paperless operation within a facility and with supply chain partners (suppliers and customers). System integration standards such as EDI bring the possibility of transferring business information automatically between systems in a very secure manner, which not only replaces paper but also makes many manual operations obsolete. In combination with Web interfaces on the Internet to enable customers and suppliers to enter data directly into the business systems, the whole issue of electronic commerce with its huge implication on business processes within a company becomes an area with many important implications for paperless operation. 

So, R. H. Y, Ling, S. H., and Tseng, M. M. (1999), Customer Behavior in Web-Based Mass-Customization Systems An Experimental Study on the Buying Decision-Making Process over the Internet, Hong Kong University of Science and Technology. 

Systems Engineering is a detailed process applied at all product levels. Good Systems Engineering processes and implementation will ensure that the final products meet the requirements of the customer. Systems Engineering is defined different ways by many constituents, but it includes some basic core steps in the process ... 

Nitrogen generators of the type pictured in Fig. 2.5 supply gaseous nitrogen to industrial gas customers. Systems of this type can be installed in a plant warehouse or utility area to provide local nitrogen requirements. Modem connections enable the units to be monitored from remote locations. 

The enterprise updates requirements views and the functional, design, and system architeetures to reflect changes brought about by a customer, systems analysis, validation and verification deviation, or management decision. The updated requirements baseline or functional, physical, or system arehiteeture is used for continuing SEP activities. 

Electrical contractors install equipment and systems in new buildings. Once a building is fully operational, the electrical contractor may provide a maintenance service to that client or customer or alternatively the client may employ an in-house electrician to maintain the installed electrical equipment. It all depends on the amount of work to be done and the complexity of the customers systems. 

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