Laboratory information management system development

Nakagawa, A.S. LIMS Implementation and Management The Royal Society of Chemistry Cambridge, UK, 1994. Hinton, M.D. Laboratory Information Management Systems Development and Implementation for a Quality Assurance Laboratory Marcel Dekker, Inc. New York, USA, 1995. 

Hinton MD (1995) Laboratory Information Management Systems Development and Implementation for a Quality Assurance Laboratory. New York Marcel Dekker. 

Laboratory information management systems, or LIMS represent an integral part of the data management systems used in preclinical development. LIMS... 

In Fig. 42.9 we show the simulation results obtained by Janse [8] for a municipal laboratory for the quality assurance of drinking water. Simulated delays are in good agreement with the real delays in the laboratory. Unfortunately, the development of this simulation model took several man years which is prohibitive for a widespread application. Therefore one needs a simulator (or empty shell) with predefined objects and rules by which a laboratory manager would be capable to develop a specific model of his laboratory. Ideally such a simulator should be linked to or be integrated with the laboratory information management system in order to extract directly the attribute values. 

Laboratory Information Management Systems (LIMS) have been developed exclusively for practical application, viz, the organization and control of working course and information flow in the laboratory (Nilsen [1996]). LIMS comprises ... 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

Modern laboratories are complex multifaceted units with vast amounts of information passing to and from instruments and computers and to and from analysts and clients daily. The development of highspeed, high-performance computers has provided laboratory personnel with the means to handle the situation with relative ease. Software written for this purpose has meant that ordinary personal computers can handle the chores. The hardware and software system required has come to be known as the laboratory information management system (LIMS). 

Computers were first used in laboratories to calculate results and generate reports, often from an individual instrument. As automated analysers were developed, so the level of computerization increased and computers now play a major role in the modem laboratory. They are associated with both the analytical and organizational aspects and the term Laboratory Information Management System (LIMS) is often used to describe this overall function. Such systems are available that link the various operations associated with the production of a validated test result, from the receipt of the sample to the electronic transmission of the report to the initiator of the request, who may be at a site removed from the laboratory. Other uses include stock control, human resource management and budgets. 

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). 

Most of the instruments used in the laboratory are commercial off-the-shelf (COTS) instruments, and consequently the users have little or no input into their design. A full system development life-cycle (SDLC) approach [8], which is used to develop complex computerized systems such as Laboratory Information Management System (LIMS) or Chromatographic Data System (CDS) or custom design laboratory equipment, is not appropriate for COTS instruments. Some laboratory instruments such as a pH meter or centrifuge are fairly simple and therefore do not warrant the SDLC approach. 

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. 

This method is used for stability, research development, and for production quality control. Hardness testers are available from many vendors and today, many labs are using bench top models that can directly be interfaced to a laboratory information management system (LIMS). Figure 10.4 shows a typical hardness tester. 

McDowall RD (1993) A matrix for the development for a strategic laboratory information management system. Analytical Chemistry 65 896A-901A. 

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