Laboratory-information-and-management system LIMS

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... 

Representation of Analytical Information 285 Laboratory Information and Management Systems (LIMS)... 

Among analytical databases, there are also systems for organizing laboratory work, for exchanging information, and for communicating within a company. They are termed laboratory information and management systems (LIMS). 

For a laboratory with a paperless workflow, these values are kept in the Laboratory Information and Management System (LIMS) and will be transferred to the CDS. Without this cross-hnking, the manual input of weightings into the CDS would signify an enormous effort and the risk of transcription errors would exist. To avoid this, two approaches for the transfer of balance data to the CDS are thinkable ... 

Communication with the database of a laboratory information and management system (LIMS) for further data-processing and archiving of results. 

A laboratory information management system (LIMS) is a computer or computer network used to automate the acquisition and management of raw analytical data. In its simplest form, it tracks samples and test results through analytical laboratories and provides summaries of the status of these samples and tests. In its most advanced form, the system is interfaced to the laboratory s instmmentation and communication network to allow automation of data gathering, compilation, and reporting. 

Laboratory Information Management System. The QC lab must analy2e raw material, in-process, and finished product samples adhere to cahbration schedules record data and perform statistical analyses. These activities lend themselves to the appHcation of software packages such as a laboratory information management system (LIMS) (qv). An inexpensive LIMS is within the reach of even small laboratories. 

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... 

Diagrams of the LMS 1100 laboratory information management system (LIMS). (After Harder and Koski,Am. Lab., 15(9), 28 (1983), with permission.)... 

Beyond simple data storage and instrument control, modern data systems provide extensive data analysis capabilities, including fitted baselines, peak start and stop tic marks, named components, retention times, timed events and baseline subtraction. Further, they provide advanced capabilities, such as multiple calibration techniques, user-customizable information and reports and collation of multiple reports. If a Laboratory Information Management System (LIMS) is available, the chromatographic data system should be able to directly transfer data files and reports to the LIMS without user intervention. The chapter by McDowall provides a terse but thorough description of the... 

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. 

A diagrammatic representation of using PAT and the Laboratory Information Management System (LIMS) controls for the manufacturing of pharma-ceuticals/biopharmaceuticals is presented in Fig. 9.6. 

On completion of an analysis, the results are checked and vahdated by the analyst and compared with preset Hmits based on permitted concentration values or consented values, before being sent electronically to the database. Any result which breaches a particular Hmit can be repeated for confirmation. About 80% of the work is fully automated in this way, with most of the major items of equipment being interfaced to the Laboratory Information Management System (LIMS). 

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. 

Chapter 6 provides specific standards and general guidelines for the vahdation of Laboratory Information Management Systems (LIMS) and other computerized laboratory systems. The chapter includes specific interpretations of the validation requirements in the post-Part 11 environment. 

Centralized laboratories offer several advantages. First, and perhaps most obviously, centrahzed operations can afford greater capital investment in state-of-the-art automation systems, top-level employees, and the most sophisticated equipment. While upgrading a Laboratory Information Management System (LIMS) on a regular basis may not be cost-effective for a small QA laboratory, it will be a practical annual expense for a company offering QA lab services to a number of clients. 

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). 

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