Laboratory informatics tools are used in laboratory environments around the world that directly touch the everyday human experience. The rapid pace of change in the area of laboratory informatics over the last six years has led to a significant revision of E1578, Guide for Laboratory Informatics.
“Laboratory informatics tools are used in lab environments across many industries, including healthcare, food, forensics, automotive, chemical, energy, manufacturing, mining, government/regulation, defense, nuclear and academic,” says James Powers, managing partner, Bridge Associates LLC, and chairman of the task group that revised the standard. “Laboratory informatics provides a vital link in the capture, processing, trending and reporting of information.”
The standard, which has been retitled from Guide for Laboratory Information Management Systems (LIMS), is under the jurisdiction of Subcommittee E13.15 on Analytical Data, part of ASTM International Committee E13 on Molecular Spectroscopy and Separation Science.
According to Powers, the scope of E1578 has been broadened to include the primary tools in today’s laboratory informatics area. Examples include laboratory information management systems; chromatography data systems; electronic laboratory notebooks; and scientific data management systems. Additional terms related to laboratory informatics are now defined, and new sections, including one on lean concepts and laboratory informatics, have been added.
“E1578 can be used to specify, select and enhance software tools used in laboratories to capture, analyze, trend and report laboratory sample, test and result information,” says Powers. “Laboratory informatics tools can directly control instruments and the capture of data, which speeds analysis, lowers costs and improves the quality of test results.”
Powers notes that information contained in this guide will benefit a broad range of people who work or interact with a laboratory. A wide segment of laboratory informatics users, vendors and interested stakeholders participated in the recent revision of the standard.
The primary audiences for the standard include end users of laboratory informatics tools; implementers of laboratory informatics tools; information technology personnel; laboratory informatics tools vendors; instrument vendors; individuals who approve laboratory informatics funding; laboratory informatics applications support specialists; and software test/validation specialists.
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This article appears in the issue of Standardization News.