ASTM_E_1578_-_13.pdf

Designation:E157813Standard Guide forLaboratory Informatics1This standard is issued under the fixed designation E1578;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide helps describe the laboratory informaticslandscape and covers issues commonly encountered at allstages in the life cycle of laboratory informatics from inceptionto retirement.It explains the evolution of laboratory informat-ics tools used in todays laboratories such as LaboratoryInformation Management Systems(LIMS),Electronic Labora-tory Notebooks(ELN),Scientific Data Management Systems(SDMS),and Chromatography Data Systems(CDS).It alsocovers the relationship(interactions)between these tools andthe external systems in a given organization.The guidediscusses supporting laboratory informatics tools and a widevariety of the issues commonly encountered at different stagesin the life cycle.The sub-sections that follow describe detailsof scope of this document in specific areas.1.2 High-Level PurposeThe purpose of this guide in-cludes:(1)helping educate new users of laboratory informaticstools,(2)provide a standard terminology that can be used bydifferent vendors and end users,(3)establish minimum re-quirements for laboratory informatics,(4)provide guidance forthe specification,evaluation,cost justification,implementation,project management,training,and documentation of thesystems,and(5)provide function checklist examples forlaboratory informatics systems that can be adopted within thelaboratory and integrated with the existing systems.1.3 Laboratory Informatics DefinitionLaboratory infor-matics is the specialized application of information technologyaimed at optimizing laboratory operations.It is a collection ofinformatics tools utilized within laboratory environments tocollect,store,process,analyze,report,and archive data andinformation from the laboratory and supporting processes.Laboratory informatics includes the integration of systems,theelectronic delivery of results to customers,and the supportingsystems including training and policies.Examples of labora-tory informatics include:Laboratory Information ManagementSystems(LIMS),Electronic Laboratory Notebooks(ELNs),Chromatography Data Systems(CDS),and Scientific DataManagement Systems(SDMS).NOTE1Laboratory informatics scope encompasses multiple technicalsolutions or systems.The division between these system categoriescontinues to soften as functionality continues to be added to each of them.LIMS were originally created to address the laboratories need to managelaboratory operations and data,provide traceability for all laboratorysamples and equipment,and ensure that laboratory procedures arefollowed.ELNs,on the other hand,were originally created to meet thescientists need to document their experimental design,execution,andconclusions in an electronic format instead of in a paper notebook.SDMSwas created to provide a repository of all scientific data files and resultsregardless of instrument type.The current definitions of each of thesesystem categories are far more encompassing.1.4 Scope Considerations When Selecting and Implement-ing Laboratory Informatics SolutionsMany laboratories havedetermined that they need to deploy multiple laboratoryinformatics systems to automate their laboratory process andmanage their data.Selection of an informatics solution requiresa detailed analysis of the laboratorys requirements rather thanby choosing a product category.It is important to includerepresentatives from Information Technology(IT)and SubjectMatter Experts(SMEs),who understand the needs of thelaboratory,to be involved in the selection and implementationof a laboratory informatics system to ensure that the needs ofthe laboratory are met and that IT can support it.Customers(internal and external)of laboratory information should also beincluded in the laboratory informatics solution design,toensure there is full electronic integration between systems.1.5 The scope of this guide covers a wide range of labora-tory types,industries,and sizes.Examples of laboratory typesand industries are listed in the following:1.5.1 General Laboratories:1.5.1.1 Standards(ASTM,IEEE,ISO),and1.5.1.2 Government(EPA,FDA,JPL,NASA,NRC,USDA,FERC).1.5.2 Environmental:1.5.2.1 Environmental Monitoring.1.5.3 Life Science Laboratories:1.5.3.1 Biotechnology,and1.5.3.2 Diagnostic.1.5.4 Healthcare Medical:1.5.4.1 Devices,1.5.4.2 Pharmaceuticals vet/animal,1.5.4.3 Public health,and1This guide is under the jurisdiction of ASTM Committee E13 on MolecularSpectroscopy and Separation Science and is the direct responsibility of Subcom-mittee E13.15 on Analytical Data.Current edition approved Aug.1,2013.Published November 2013.Originallyapproved in 1993.Last previous edition approved