ASTM E1578-2006 Standard Guide for Laboratory Information Management Systems (LIMS)《实验室信息管理系统(LIMS)的标准指南》.pdf

1、Designation: E 1578 06Standard Guide forLaboratory Information Management Systems (LIMS)1This standard is issued under the fixed designation E 1578; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A numbe

2、r in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide covers issues commonly encountered at allstages in the life cycle of Laboratory Information ManagementSystems from inception to

3、retirement. The sub-sections thatfollow describe details of scope of this document in specificareas.1.2 High Level PurposeThe purpose of this guide in-cludes: (1) help educate new users of Laboratory InformationManagement Systems (LIMS), (2) provide standard terminol-ogy that can be used by LIMS ven

4、dors and end users, (3)establish minimum requirements for primary LIMS functions,(4) provide guidance for the specification, evaluation, costjustification, implementation, project management, training,and documentation, and (5) provide an example of a LIMSfunction checklist.1.3 LIMS DefinitionThe te

5、rm Laboratory InformationManagement Systems (LIMS) describes the class of computersystems designed to manage laboratory information.1.4 Laboratory CategoriesThe spectrum of laboratoriesthat employ LIMS is wide spread. The following break downprovides an overview of the laboratory categories that use

6、LIMS as well as examples of laboratories in each category.1.4.1 General Laboratories:1.4.1.1 Standards (ASTM, IEEE, ISO), and1.4.1.2 Government (EPA, FDA, JPL, NASA, NRC, USDA,FERC).1.4.2 Environmental:1.4.2.1 Environmental Monitoring.1.4.3 Life Science Laboratories:1.4.3.1 Biotechnology,1.4.3.2 Dia

7、gnostic,1.4.3.3 Healthcare Medical,1.4.3.4 Devices, and1.4.3.5 Pharmaceuticals Vet/Animal.1.4.4 Heavy Industry Laboratories:1.4.4.1 Energy 40 FR3210D, Jan. 20, 1975FDA CFR Part 50, Appendix E 10 Code of Federal Regu-lations (CFR) Part 50 Appendix E. 45 FR 55410, Aug. 19,1980, et sequentia as amended

8、FDA CFR Part 50, Appendix K 10 Code of Federal Regu-lations (CFR) Part 50 Appendix K. 21 FR 355, Jan. 19,1956, unless otherwise noted3. Terminology3.1 This guide defines terminology used in the LIMS field.Section 3.2 defines LIMS terms specific to this guide. Users ofthis document should request a t

9、erminology list from eachvendor with a cross reference to the terms used in this guide.3.2 Definitions of Terms Specific to This Standard:3.2.1 CAPA, nacronym for corrective action, preventativeaction.3.2.2 Chromatography Data System (CDS), ncomputersystem used to acquire, analyze, store and report

10、informationfrom chromatography instruments.3.2.3 EDMS, nacronym for electronic document manage-ment system.3.2.4 ELN, nacronym for electronic laboratory puter system designed to replace paper laboratory note-books.3.2.4.1 DiscussionLab notebooks in general are used byscientists and technicians to do

11、cument research, experimentsand procedures performed in a laboratory. A lab notebook isoften maintained to be a legal document and may be used in acourt of law as evidence. Similar to an inventors notebook, thelab notebook is also often referred to in patent prosecution andintellectual property liti

12、gation. Electronic laboratory notebooksenable electronic access to information including searching,data capture from instruments and collaboration betweenlaboratory personnel and personnel outside the laboratory.3.2.4.2 DiscussionELNs can be divided into two catego-ries: specific ELNs contain featur

13、es designed to work withspecific applications, scientific instrumentation or data types.Refer to laboratory exectuion system (LES) as an example ofa specific ELN. Cross-disciplinary ELNs or generic ELNs aredesigned to support access to all data and information thatneeds to be recorded in a lab noteb

14、ook.3.2.5 ERP, nacronym for enterprise resource planning.3.2.6 GALP, nthe GALPs are a union of federal regula-tions, policies, and guidance documents. Several of the GALPprovisions are embodied in EPAs Good Laboratory PracticeStandards (GLPs). The GLPs are regulations that govern themanagement and c

15、onduct of most nonclinical laboratory stud-ies submitted to EPAs office of Toxic Substances and its Officeof Pesticide Programs. Reference EPA 2185.3.2.7 GAMP, nacronym for good automated manufactur-ing practice.3.2.8 LES, nacronym for laboratory execution system.Computer system employed in the labo

16、ratory at the analystwork level to aid in step enforcement for laboratory testmethod execution.3.2.8.1 DiscussionLaboratory execution systems (LES)are a sub class of electronic laboratory notebooks (ELNs) thatfocus on step execution of defined laboratory test methods. TheLES are typically employed i

17、n Quality Control laboratoriesthat have defined test methods. The functionality of LES andLIMS overlap in the areas of result entry, instrument integra-tion and specification flagging. Deployment options includeLES and LIMS systems deployed as an integrated solution,LIMS only or LES only (for limite

18、d functions).3.2.9 Laboratory Information Management System (LIMS),n(1) acronym for laboratory information management Sys-tem. Computer application(s) software and hardware that canacquire, analyze, report, and manage data and information inthe laboratory; (2) computer software that is used in thela

19、boratory for the management of samples, test results, labo-ratory users, instruments, standards and other laboratory func-tions such as invoicing, plate management, stability LIMS,work flow automation; and (3) a class of application softwarewhich handles storing and managing of information generated

20、by laboratory processes. These systems are used to managelaboratory processes including defining master data, samplemanagement and chain of custody, work assignment, instru-ment and equipment management, standard and reagent man-agement, scheduled sample collection and testing, result entry,result r

21、eview, reporting, trending and business rule enforce-ment. These systems interface with laboratory instruments (forexample, chromatography data systems (CDS), spectropho-tometers and balances) and other information systems suchenterprise resource planning (ERP), manufacturing executionsystems (MES),

22、 or health care based laboratory informationsystems).ALIMS is a highly flexible application, which can beconfigured or customized to facilitate a wide variety oflaboratory workflow models.3.2.10 LIMS configuration, nrefers to the process ofpreparing the LIMS for use in a particular laboratory. Ittyp

23、ically involves using an interface provided by the vendor toenter information that describes the types of samples, analyti-cal methods, specifications, etc. used in the laboratory.10Available from US EPAhttp:/www.epa.gov/superfund/programs/clp/sedd.htm11Available from International Organization for

24、Standardization (ISO).12Available from U.S. Nuclear Regulatory Commission (NRC), PDR, 01F13,Washington, DC 20555.E15780633.2.11 LIMS customization, nrefers to the process ofmodifying the LIMS to meet the requirements of a particularlaboratory. It typically involves adding tables, modifying tablestru

25、ctures and writing code or programs to alter the behavior ofthe LIMS.3.2.12 metadata, n(1) data about data; and (2) informa-tion that describes another set of data.3.2.12.1 DiscussionMetadata in the LIMS context typi-cally includes all data that supports a test result that is recordedin a LIMS. Exam

26、ples include for a pH test, a pH result can besupported by metadata including what instrument was used,what is the calibration date of the instrument, what standardbuffer solutions (reagents) were used to calibrate the pH probesensor and the expiration dates for the standard solutions.sample3.2.13 s

27、ample registration, nthe process of registeringsamples in a LIMS.3.2.14 SDMS, nacronym for scientific data managementsystem.3.2.15 spectroscopic data systems, ncomputer systemused to process, visualize, interpret, store and report informa-tion from spectroscopic and non-chromatographic instruments.3

28、.2.16 static tables, ndescriptive LIMS database tableswhere templates, tests, calculations, specifications, and relatedinformation are defined and stored (commonly found in “lookup/reference/dictionary” tables).3.2.16.1 DiscussionLIMS stores look up information tospeed sample registration and test a

29、ssignments. Generally priorto sample registration the static tables need to be configured.Some LIMS implementations can enter static table informationdirectly from the sample registration step. Synonyms of statictables include master data and configuration data.4. Significance and Use4.1 RelevanceTh

30、is guide is intended to educate those inthe intended audience on many aspects of LIMS. Specifically,the guide may:4.1.1 Help educate new users of LIMS;4.1.2 Help educate general audiences in laboratories andother organizations that use LIMS;4.1.3 Help educate instrument manufactures and producersof

31、other commonly interfaced systems;4.1.4 Provide standard terminology that can be used byLIMS vendors and end users;4.1.5 Establish a minimum set of requirements for primaryLIMS functions;4.1.6 Provide guidance on the tasks performed and docu-mentation created in the specification, evaluation, cost j

32、ustifi-cation, implementation, project management, training, anddocumentation of LIMS; and4.1.7 Provide high-level guidance for the integration ofLIMS with the most commonly integrated systems such aslaboratory instruments, CDS, ERP, ELN, SDMS and so forth.4.2 How UsedThis guide is intended to be us

33、ed by allstakeholders involved in any aspect of LIMS implementationor maintenance.4.2.1 It is intended to be used throughout the LIMS lifecycle by individuals or groups responsible for LIMS includingspecification, build/configuration, validation, use, upgrades,retirement/decommissioning.4.2.2 It is

34、also intended to provide an example of a LIMSfunction checklist.5. LIMS Concept ModelGraphic Picture ofFunctionalityNOTE 1The LIMS primary functions, integration points, life cycleand industry segments are described in Fig. 1.5.1 LIMS Concept ModelHigh LevelThe core LIMSfunctions cover a wide range

35、of laboratory workflows, infor-mation management and integration with other enterprisecomputer systems. These core LIMS functions are illustrated inthe LIMS box. Integration with LIMS and a number of externalsystems, instruments, reporting tools and automated test toolsare illustrated by the boxes a

36、bove and below the LIMS box inFig. 1.5.2 LIMS Concept ModelMid LevelThe LIMS func-tions and their relationship with external systems, extendedLIMS functions and future LIMS functions is illustrated in Fig.2. The diagram defines:5.2.1 Core LIMS functions (LC) with sub-divisions ofLC-1.X Operations an

37、d LC-2.X Support;5.2.2 Extended LIMS functions are described by itemslisted in boxes LE-X;5.2.3 Systems external to LIMS are illustrated with boxescoded with E; and5.2.4 Future LIMS functions are described in boxes codedwith LF.5.3 LIMS Life Cycle PhasesFig. 3 defines the high levelLIMS life cycle p

38、hases of (1) initial LIMS implementation, (2)LIMS operations, and (3) system maintenance. Each of theseprimary phases is further decomposed into primary functions.The numbering scheme use matches the mid level definitions inFig. 2 and also tie to the requirements section located inAppendix X1.5.4 LI

39、MS Concept ModelIndustry SegmentsAll labora-tories require basic LIMS work flow including sample regis-tration, assignment of tests, entry of results, review andapproval and reporting. Laboratories in various industries mayrequire additional functionality to meet special workflowrequirements. An env

40、ironmental laboratory for example mayrequire tracking of sample containers, processing of samples inbatches with control samples, instrument integration to addressthe number of components reported, and multiple levels ofreview. There also may be specific reporting requirements. Fig.4 illustrates som

41、e of the additional functions that may berequired to address the needs of laboratories in particularindustry segments. The functions illustrated would be over andabove the basic laboratory workflow.6. LIMS Workflow and Sample Lifecycle6.1 LIMS Workflow IntroductionThe LIMS workflowmodel (see Fig. 5)

42、 provides a generic representation of theprocess flow in a typical laboratory. The purpose of the workflow diagram is to elucidate the LIMS functions and interactionE1578064points with typical laboratory work processes (processing ofsamples, analysis and reporting). Specific laboratory require-ments

43、 will vary widely from one laboratory to another. Thedefinition and composition of a sample or collection of sampleswill also be specific to an individuals laboratory, and willchange significantly from industry to industry. The individualsown laboratory workflow and sample definition should bedefine

44、d as part of the LIMS life cycle. Fig. 5 explains the basicLIMS functions and workflow interactions. The numbers in theparentheses in 6.2 refer to specific workflow processes(bubbles) in Fig. 5, which in turn relate to the areas shown inthe LIMS concepts models (Figs. 1-4) in Section 5. To providecl

45、ear examples of what may be performed in each of the workflow model functions, items from all levels of the LIMSconcept model are used. The description in 6.2 does not includeevery concept model function and is not limited to a particularlevel.6.2 Generic LIMS WorkflowFig. 5 shows both the logicalda

46、taflow through the LIMS process in combination with thecorresponding physical sample processes. Each box in Fig. 5 isuniquely numbered (cross reference toFig. 2 and described indetail in subsequent sections.6.3 LIMS Functional AreasThe following section de-scribes the generic LIMS workflow steps as

47、outlined in Fig. 5.Each step is described with a cross reference to Fig. 2. Theindex number show in parentheses refers to both Fig. 2 and theAppendix X1.6.3.1 Sample Registration (LC-1.1):6.3.1.1 The initiation of a request for testing/sampling startsthe process. Examples of sample requests include

48、manualforms, electronic forms, phone requests, web requests, process-driven requests, time or calendar-based requests, ad-hoc re-quests, and LIMS-generated requests. Information obtainedfrom the sample request includes biographical, client, re-quested test(s), and safety information. Some LIMS imple

49、men-tations allow the laboratory to pre-log or post-log samples orthe client to pre-log samples through a web portal.6.3.1.2 The LIMS must first be properly configured and therelatively fixed information about personnel, customers, tests,reports, and the like must be entered into the static tables.Afterthe LIMS is configured, the process begins with a sampleregistration. The LIMS assigns a unique number to eachsample that is registered. The unique number can be asequential integer or a user-defined sequence. Multiple samplesthat are s