Managing and validating laboratory information systems


The laboratory industry is quickly moving into the era of electronic reports, transmission of information via the Internet, etc., and there is a need to develop guidelines that can provide consistency in the industry.A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based laboratory and information management system with features that support a modern laboratory's operations.This typically is initiated when a sample is received in the laboratory, at which point the sample will be registered in the LIMS.Some LIMS will allow the customer to place an "order" for a sample directly to the LIMS at which point the sample is generated in an "unreceived" state.In 1982 the first generation of LIMS was introduced in the form of a single centralized minicomputer, which offered laboratories the first opportunity to utilize automated reporting tools.As the interest in these early LIMS grew, industry leaders like Gerst Gibbon of the Federal Energy Technology Center in Pittsburgh began planting the seeds through LIMS-related conferences.



As laboratory demands change and technological progress continues, the functions of a LIMS will likely also change.Despite these changes, a LIMS tends to have a base set of functionality that defines it.That functionality can roughly be divided into five laboratory processing phases, with numerous software functions falling under each: (1) the reception and log in of a sample and its associated customer data, (2) the assignment, scheduling, and tracking of the sample and the associated analytical workload, (3) the processing and quality control associated with the sample and the utilized equipment and inventory, (4) the storage of data associated with the sample analysis, (5) the inspection, approval, and compilation of the sample data for reporting and/or further analysis There are several pieces of core functionality associated with these laboratory processing phases that tend to appear in most LIMS: The core function of LIMS has traditionally been the management of samples."LIS" has tended to refer to laboratory informatics systems in the forensics and clinical markets, which often required special case management tools.

"PDES" has generally applied to a wider scope, including, for example, virtual manufacturing techniques, while not necessarily integrating with laboratory equipment.

Key features include—but are not limited to—workflow and data tracking support, flexible architecture, and data exchange interfaces, which fully "support its use in regulated environments".



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