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Laboratory integrated management system LIMS

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... [Pg.222]

Laboratory Information Management Systems (LIMS) are computer software-based integrators for laboratory reports generation. They gather all the information on a particular sample, including history, source, supplier addressing, data reports from all wet and analytical instruments, and conclusions and results drawn from this analysis. They receive information from a variety of inputs, in a variety of formats, and must have inputs for data confirmation and checking. [Pg.177]

Laboratory information management systems, or LIMS represent an integral part of the data management systems used in preclinical development. LIMS... [Pg.57]

The system scope Where does a laboratory begin and end Clear definition of these two points helps to determine the scope of a LIMS. The six areas of system scope that define the matrix are laboratory operations, monitor and control of operations, laboratory management, reporting and communications, analytical decision-making, and organizational integration. This is the maximum scope of a LIMS. These comprise the horizontal axis of the matrix. The function carried out by each of these areas is outlined in Table 1. [Pg.4069]

Until 1990 Sample management, entry of results, printing of reports, laboratory information system, CAQ Integration of several laboratories in organizations LIMS user in laboratory and production planner Central/decentraUzed systems, relational cbtabases, first PC systems (DOS)... [Pg.1466]


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