ASTM E1578-2018 Standard Guide for Laboratory Informatics.pdf

1、Designation: E1578 18Standard 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 t

2、he 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 incep

3、tionto retirement. It explains the evolution of laboratory informat-ics tools used in todays laboratories such as laboratoryinformation management systems (LIMS), laboratory execu-tion systems (LES), laboratory information systems (LIS),electronic laboratory notebooks (ELN), scientific data manage-m

4、ent systems (SDMS), and chromatography data systems(CDS). It also covers the relationship (interactions) betweenthese tools and the external systems in a given organization.The guide discusses supporting laboratory informatics toolsand a wide variety of the issues commonly encountered atdifferent st

5、ages in the life cycle. The subsections that followdescribe the scope of this document in specific areas.1.2 High-Level PurposeThe purpose of this guide in-cludes: (1) educating new users on laboratory informaticstools; (2) providing a standard terminology that can be used bydifferent vendors and en

6、d users; (3) establishing minimumrequirements for laboratory informatics; (4) providing guid-ance for the specification, evaluation, cost justification,implementation, project management, training, and documen-tation of the systems; and (5) providing a functional require-ments checklist for laborato

7、ry informatics systems that can beadopted within the laboratory and integrated with existingsystems.1.3 Laboratory Informatics DefinitionLaboratory infor-matics is the specialized application of information technologyaimed at optimizing laboratory operations. It is a collection ofinformatics tools u

8、tilized within laboratory environments tocollect, store, process, analyze, report, and archive data andinformation from the laboratory and its supporting processes.Laboratory informatics includes the effective use of criticaldata management systems, the electronic delivery of results tocustomers, an

9、d the use and integration of supporting systems(for example, training and policy management). Examples ofprimary laboratory informatics tools include laboratory infor-mation management systems (LIMS), laboratory executionsystems (LES), laboratory information systems (LIS), elec-tronic laboratory not

10、ebooks (ELN), scientific data managementsystems (SDMS), and chromatography data systems (CDS).1.4 Scope Considerations when Selecting and ImplementingLaboratory Informatics SolutionsMany laboratories havedetermined that they need to deploy multiple laboratoryinformatics systems to automate their lab

11、oratory processes andmanage their data. Selection of an informatics solution requiresa detailed analysis of the laboratorys requirements and shouldnot be a simple product category decision. Information tech-nology (IT) representatives and subject matter experts (SMEs)who understand the needs of the

12、laboratory need to be involvedin the selection and implementation of a laboratory informaticssystem to ensure that the needs of the laboratory are met and ITcan support it. Customers (internal and external) of laboratoryinformation should also be included in the laboratory informat-ics solution desi

13、gn to ensure full electronic integration betweensystems.1.5 The scope of this guide covers a wide range of labora-tory types, industries, and sizes. Examples of laboratory typesand industries include:1.5.1 General Laboratories:1.5.1.1 Standards (ASTM, IEEE, ISO) and1.5.1.2 Government (EPA, FDA, JPL,

14、 NASA, NRC, USDA,USGS, 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 and Medical:1.5.4.1 Bionomics/genomics,1.5.4.2 Medical devices,1.5.4.3 Pharmaceutical,1.5.4.4 Veterinary,1.5.4.5 Public healt

15、h, and1.5.4.6 Hospital.1.5.5 Heavy Industry Laboratories:1.5.5.1 Energy and resources,1.5.5.2 Manufacturing and construction,1.5.5.3 Materials and chemicals, and1This guide is under the jurisdiction of ASTM Committee E13 on MolecularSpectroscopy and Separation Science and is the direct responsibilit

16、y of Subcom-mittee E13.15 on Analytical Data.Current edition approved Aug. 1, 2018. Published September 2018. Originallyapproved in 1993. Last previous edition approved in 2013 as E1578-13. DOI:10.1520/E1578-18.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 1

17、9428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Tec

18、hnical Barriers to Trade (TBT) Committee.11.5.5.4 Transportation and shipping.1.5.6 Food and Beverage Laboratories:1.5.6.1 Agriculture,1.5.6.2 Beverages,1.5.6.3 Food, and1.5.6.4 Food service and hospitality.1.5.7 Public Sector Laboratories:1.5.7.1 Law enforcement/forensic,1.5.7.2 State and local gov

19、ernment,1.5.7.3 Education and nonprofits, and1.5.7.4 Public utilities (water, electric, waste treatment).1.6 IntegrationThe scope of integration covered in thisguide includes communication and meaningful data exchangebetween different laboratory informatics tools and other exter-nal systems (documen

20、t management, chromatography datasystems, laboratory instruments, spectroscopy data systems,enterprise resource planning (ERP), manufacturing executionsystems (MES), investigations/deviations and CAPA manage-ment systems), and other integrated business systems (forexample, clinical or hospital envir

21、onments) provide significantbusiness benefits to any laboratory and is discussed at a highlevel in this guide.1.7 Life-Cycle PhasesThe scope of this guide is intendedto provide an understanding of laboratory informatics toolslife cycle from project initiation point to retirement anddecommissioning.

22、This guide was designed to help neweraudiences in understanding the complexity in the relationshipsbetween different laboratory informatics tools and how to planand manage the implementation project, while seasoned usersmay use the different life cycles to maintain existing laboratoryinformatics too

23、ls. Integrating additional informatics tools toexisting ones in todays evolving laboratory environment addsconstraints that need to be considered. The life-cycle discus-sion includes both the laboratory informatics solution life cycleas well as the project life cycle.1.7.1 The product life cycle enc

24、ompasses a specific labora-tory informatics system and the expected useful life of thatsystem before it needs to be replaced or upgraded.1.7.2 The project life cycle encompasses the activities toacquire, implement, operate, and eventually retire a specificlaboratory informatics system.1.8 AudienceTh

25、is guide has been created with the needsof the following stakeholders in mind: (1) end users oflaboratory informatics tools, (2) implementers of laboratoryinformatics tools, (3) quality personnel, (4) information tech-nology personnel, (5) laboratory informatics tools vendors, (6)instrument vendors,

26、 (7) individuals who approve laboratoryinformatics tools funding, (8) laboratory informatics applica-tions support specialists, and (9) software test/validation spe-cialists. Information contained in this guide will benefit a broadaudience of people who work in or interact with a laboratory.New user

27、s can use this guide to understand the purpose andfunctions of the wide variety of laboratory informatics tools aswell as the interactions between these tools with externalsystems. The guide can also help prospective users in under-standing terminology, configurations, features, design, benefits,and

28、 costs of these different laboratory informatics tools.Individuals who are purchasing specific tools may also use thisguide to identify functions that are recommended for specificlaboratory environments. Research and development staff ofdifferent commercial laboratory informatics systems vendorsmay

29、use the guide as a tool to evaluate, identify, and potentiallyimprove the capabilities of their products. The vendors salesstaff may use the guide to represent functions of their labora-tory informatics products to prospective customers in moregeneric and product-neutral terms.1.9 Out of ScopeThis g

30、uide does not attempt to define theboundaries of laboratory informatics, as they continue toevolve and blur between the different types of tools; rather, itfocuses on the functionality that is provided by laboratoryinformatics as a whole.1.10 This international standard was developed in accor-dance

31、with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standa

32、rds:2E1394 Specification for Transferring Information BetweenClinical Instruments and Computer Systems (Withdrawn2002)3E1947 Specification for Analytical Data Interchange Proto-col for Chromatographic DataE1948 Guide for Analytical Data Interchange Protocol forChromatographic DataE2077 Specification

33、 for Analytical Data Interchange Proto-col for Mass Spectrometric DataE2078 Guide for Analytical Data Interchange Protocol forMass Spectrometric DataE2369 Specification for Continuity of Care Record (CCR)2.2 CDISC Standard:4SEND Standard for Exchange of Nonclinical Data;2.3 CIDX Standard:5CIDX Chemi

34、stry Industry Data eXchange2.4 EPA Standard:6ESAR Environmental Sampling, Analysis and Results DataStandard2.5 FDA Regulation:721 CFR Part 11 Electronic Records; Electronic Signatures,62 FR 134642For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at

35、serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from Clinical Data Interchange Standards Consortium (CDISC), 401West 15

36、th Street, Suite 800, Austin, TX 78701, https:/www.cdisc.org/.5The CIDX Chem eStandards are available at OAGi, P.O. Box 4897, Marietta,GA 30061-4897, http:/www.oagi.org/.6Available from United States Environmental Protection Agency (EPA), 1200Pennsylvania Ave., NW, Washington, DC 20460, http:/www.ep

37、a.gov/.7Available from U.S. Food and Drug Administration (FDA), 10903 NewHampshire Ave., Silver Spring, MD 20993, http:/www.fda.gov.E1578 182FDA Data Integrity and Compliance with CGMP: Guidancefor Industry2.6 HL7 Standards:Health Level Seven8Standards2.7 ICH Standard:9ICH Quality Guideline Q9 Quali

38、ty Risk Management2.8 IEEE Standards:10IEEE 1012 Standard for System, Software, and HardwareVerification and ValidationIEEE 1028 Standard for Software Reviews and Audits2.9 ISA Standard:11ANSI/ISA-95.00.06 Enterprise-Control System Integration-Part 6: Messaging Service Model2.10 ISO Standards:12ISO/

39、IEC/IEEE 12207 Systems and software engineering -Software life cycle processesISO/IEC 27000 Information technology - Security tech-niques - Information security management systems -Overview and vocabularyISO/HL7 27932 Data Exchange Standards - HL7 ClinicalDocument Architecture, Release 2ISO/IEEE 110

40、73-10101 Health informatics - Point-of-caremedical device communication - Part 10101: Nomencla-tureISO/IEC/IEEE 26511 Systems and software engineering -Requirements for managers of user documentationISO/IEC/IEEE 26512 Systems and software engineering -Requirements for acquirers and suppliers of info

41、rmationISO/IEC/IEEE 29119-4 Systems and software engineering -Software testing - Part 4: Test techniquesISO/IEC/IEEE 29119-5 Systems and software engineering -Software testing - Part 5: Keyword-Driven TestingISO/IEC/IEEE 29148 Systems and software engineering -Life cycle processes - Requirements eng

42、ineering2.11 ISPE GAMP13Guides:ISPE GAMP 5: A Risk-based Approach to Compliant GxPComputerized SystemsISPE GAMP Guide: Records anelectronic system on which to create, store, retrieve, and sharefully electronic records in ways that meet all legal, regulatory,technical, and scientific requirements.3.2

43、.9.1 DiscussionLaboratory notebooks, in general, areused by scientists, engineers, and technicians to documentresearch, experiments, and procedures performed in a labora-tory. A laboratory notebook is often maintained to be a legaldocument and may be used in a court of law as evidence.Similar to an

44、inventors notebook, the laboratory notebook isalso often referred to in patent prosecution and intellectualproperty litigation.3.2.10 electronic signature, nelectronic representation ofa handwritten signature.3.2.11 enterprise resource planning, ERP, ncomputer sys-tem to integrate different types of

45、 data such as inventory levels,product orders, manufacturing capacity, inspection results,accounting data, and customer relationship management infor-mation from organizations within an enterprise (company),facilitating the flow of information between various businessfunctions across a company as we

46、ll as with outside businesspartners.3.2.12 good automated manufacturing practice forum,GAMP Forum, nvolunteer group under the auspices of theInternational Society of Pharmaceutical Engineering (ISPE) forwriting guidance for the validation of computerized systemsused in the regulated portions of the

47、pharmaceutical and alliedindustries and it is specifically designed to aid suppliers andusers in the pharmaceutical industry.3.2.13 integration broker, nmessaging application thatcan receive or extract data from a source system at theappropriate time, transform the data, and route the reformatteddat

48、a to the target node.3.2.13.1 DiscussionAn integration broker application canalso provide a repository for archiving, searching, and retriev-ing these messages.3.2.14 internet of things, IoT, nsystem of objectscomputing devices, machines, objects, people, animals, and soforththat can connect to a ne

49、twork and communicate amongthemselves, often without human intervention.3.2.14.1 DiscussionAn IoT device is an object operatingwithin that system.3.2.15 laboratory execution system, LES, ncomputer sys-tem used in the laboratory at the analyst work level to aid instep enforcement for laboratory test method execution.3.2.15.1 DiscussionLES focus on step execution of de-fined laboratory test methods. The LES is typically used inquality control laboratories that have defined test methods. Thefunctionality of a LES and a laboratory information m