Laboratory Information Management System implementation

Resin, A. (2002) A quality laboratory information management system implementation at a worldwide level. Spectra Analyse, 31 (229), 31-33. 

The SGX Laboratory Information Management System (LIMS) is based on an Oracle database platform. As an enterprise level relational database, Oracle is robust and can be expanded to meet any future needs. The expense to implement and maintain the database and to create the tools to retrieve the data stored within, including an administrator dedicated to managing the system, can be significant. At SGX, use of the LIMS to monitor all of our scientific activities reduces the incremental cost to the beamline to an acceptable level. 

Incorrectly implemented calculations moving averages in Supervisory Control and Data Acquisition (SCADA) systems, material mixing concentrations in DCS systems, flawed shelf-life date calculations in Laboratory Information Management Systems (LIMS). 

One of the major factors to be considered when implementing a GxP-compliant EDMS is validation. The basic validation approach is no different from that applied to other information management systems such as MRP 11 or Laboratory Information Management Systems (LIMS). An approach based on the validation life cycle in GAMP is appropriate. Figure 34.3 shows how validation documentation relates to typical project activities. Validation permeates all stages of the implementation process, as described below. 

This article describes what a Laboratory Information Management System (LIMS) is and provides a discussion on building vs. buying a LIMS. It also discusses the cost of a LIMS system, how to write a user requirements specification (URS), how to assess the vendors answers to the URS, the implementation of the system, and the organization around a LIMS system. 

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. 

It has been mentioned already that there are different levels of sophistication with regard to the involvement of computer applications in GLP studies and test facilities. These levels may range from the complex problems involved in the GLP compliant management of computer networks and of laboratory information management systems (LIMS) to the question of whether a simple instrument controlled by a built-in, pre-programmed chip should be treated in the same, extensive way with regard to software validation . It is certainly self-evident, as these two examples demonstrate, that not all types of IT applications have to be considered as equal with regard to GLP compliance it may indeed be impossible to do so. As it is commonplace nowadays that the silicon chip penetrates the operation of practically all kinds of work, the elucidation of its involvement in the operations of test facilities becomes an essential part of the implementation of GLP. 

McDowall, R.D. (Ed.), Laboratory Information Management Systems, Concepts, Integration, Implementation, Sigma Press, 1987. 

Laboratory systems such as Laboratory Information Management Systems (LIMS) have also come under increased regulatory scrutiny as the complexity of the software they deploy has become more advanced. Currently, there are often two LIMS tiers of control, data acquisition and data processing, often implemented by two coupled LIMS applications. The data acquisition LIMS is likely, however, to disappear in the longer term as analytical... 

The advent and implementation of laboratory information management systems has provided many opportunities for expert system technologies. Prioritizing samples and instruments and scheduling workloads can be undertaken using expert systems, in addition to summarizing and reporting on the analytical results obtained. 

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

The International Standards Organization 9000 (ISO 9000) standard, developed by the European Economic Community (EEC), also impacts manufacturers implementation of LIMS systems. ISO 9000 is a set of standards which are required for manufacturers selling products to the EEC. The 9000 standards are credited with playing an important part in the impetus to greater computerization of laboratory information management (9). 

This paper describes the design and implementation of a versatile computerized laboratory automation and information management system. Discussion highlights its adaptability to a variety of laboratory environments. 

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. 

---