Laboratory information management systems planning system

Table Bl. Example Monitoring Plan for VMS Server Running a Laboratory Information Management System ... 

The basic validation approach is no different from that applied to other information management systems, such as a Manufacturing Resource Planning (MRPll) system or a Laboratory Information Management System (LIMS). An approach based on the validation life cycle in GAMP [4] is appropriate. Figure 10.3 shows how validation documentation relates to the project activities. 

When the analytical laboratory is not responsible for sampling, the quality management system often does not even take these weak links in the analytical process into account. Furthermore, if sample preparation (extraction, cleanup, etc.) has not been carried out carefully, even the most advanced, quality-controlled analytical instruments and sophisticated computer techniques cannot prevent the results of the analysis from being called into question. Finally, unless the interpretation and evaluation of results are underpinned by solid statistical data, the significance of these results is unclear, which in turn greatly undermines their merit. We therefore believe that quality control and quality assurance should involve all the steps of chemical analysis as an integral process, of which the validation of the analytical methods is merely one step, albeit an important one. In laboratory practice, quality criteria should address the rationality of the sampling plan, validation of methods, instruments and laboratory procedures, the reliability of identifications, the accuracy and precision of measured concentrations, and the comparability of laboratory results with relevant information produced earlier or elsewhere. 

Computerized Information System. The Project SEARCH Criminalistics Laboratory Information System (CLIS) Committee is another LEAA funded project. Approximately fifteen criminalists are serving on the CLIS Committee which is conducting a requirements analysis for a nationwide computerized crime laboratory information system. With the assistance of a technical subcontractor, PRC Public Management Services, Inc., the committee has determined the "user needs" for such a data system, a conceptual design of a computer system to meet these requirements, and an assessment of different organizational and equipment alternatives for the system. The most recent task reports and implementation plan have been completed and submitted to the advisory committee for final review. Copies of the final reports should be ready for dissemination in the very near future. 

Scope of Validation The boundaries of the validation project must be defined to ensure that there is full coverage. For example, will the analytical equipment or Chromatography Data System interfaces be validated as part of the project, will Supplier Evaluations be required, etc. It is very important at this stage to determine what is within the scope of the LIMS Validation Plan and what will be validated under other associated Validation Plans. The validation of the implementation of processes and information management within the laboratory should be managed as a cohesive whole to ensure that all parts of the LIMS are developed and validated to the appropriate standards. This may be achieved by the use of a Validation Master Plan (VMP) for all the laboratory processes and information management. The Validation Plan for the LIMS and any associated plans for other interfaced systems would be referenced in and be under the control of this VMP. 

The first step is for someone in management to recognize the need for computer systems validation and to gather the other management expertise necessary to address the issue. This person is usually someone in the Quality Assurance Unit (QAU) or the computer operations, Management Information Systems - MIS, group. While these two departments need to be involved, computer systems users such as laboratory leaders, study directors, and other affected department managers need to be included in the development of a computer systems validation plan. 

What are the trends in LIMS evaluation The current systems mainly support sample management and are related to analytical laboratories. Future systems have to be enhanced with functions for planning and managing projects. Laboratories in the fields of research and development as well as in preparative chemistry are less well supported. In newer developments LIMSs are acquiring the character of organization information systems with interfaces to other internal and external information systems. Current LIMSs collect, process, print, and manage information, but they do not learn . Plausibility is checked only on a numerical basis without analytical experience. A possible trend is in the direction of expert systems, but such systems may prove too expensive. 

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