Laboratory Information Management System computerized instrument

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... 

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. 

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. 

Figure IAl-1 shows the major components of a paperless laboratory. First, a computerized analytical instrument is required to acquire, manipulate, and process the data. The instrument may be connected to its own data system, as are many chromatography instruments, or directly to an electronic laboratory notebook. The notebook often provides input to a laboratory information management system (LIMS), as discussed in section 4H-2, and to a laboratory data-archiving system. In some cases, information from the data system or notebook flows directly into archival storage. Several of these components are discussed in this case study.

A computerized laboratory can utilize a software package called a laboratory information and management system (LIMS) to carry out or control all of these requirements provided that computerized instrumentation, computer terminals, printers and plotters, disk drives etc. are linked together in a local... 

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