ASTM E1578-2013 Standard Guide for Laboratory Informatics《实验室信息的标准指南》.pdf

1、Designation: E1578 06E1578 13Standard Guide forLaboratory Information Management Systems(LIMS)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 r

2、evision. 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 informatics landscape and covers issues commonly encountered at all stages in theli

3、fe cycle of laboratory informatics from inception to retirement. It explains the evolution of laboratory informatics tools used intodays laboratories such as Laboratory Information Management Systems from inception to retirement. The (LIMS), ElectronicLaboratory Notebooks (ELN), Scientific Data Mana

4、gement Systems (SDMS), and Chromatography Data Systems (CDS). It alsocovers the relationship (interactions) between these tools and the external systems in a given organization. The guide discussessupporting laboratory informatics tools and a wide variety of the issues commonly encountered at differ

5、ent stages in the life cycle.The sub-sections that follow describe details of scope of this document in specific areas.1.2 High Level High-Level PurposeThe purpose of this guide includes: (1) helphelping educate new users of LaboratoryInformation Management Systems (LIMS), laboratory informatics too

6、ls, (2) provide a standard terminology that can be used byLIMSdifferent vendors and end users, (3) establish minimum requirements for primary LIMS functions, laboratory informatics, (4)provide guidance for the specification, evaluation, cost justification, implementation, project management, trainin

7、g, anddocumentation, documentation of the systems, and (5) provide an example of a LIMS function checklist.function checklistexamples for laboratory informatics systems that can be adopted within the laboratory and integrated with the existing systems.1.3 LIMS Laboratory Informatics DefinitionThe te

8、rm Laboratory Laboratory informatics is the specialized application ofinformation technology aimed at optimizing laboratory operations. It is a collection of informatics tools utilized within laboratoryenvironments to collect, store, process, analyze, report, and archive data and information from th

9、e laboratory and supportingprocesses. Laboratory informatics includes the integration of systems, the electronic delivery of results to customers, and thesupporting systems including training and policies. Examples of laboratory informatics include: Laboratory InformationManagement Systems (LIMS) de

10、scribes the class of computer systems designed to manage laboratory information.(LIMS),Electronic Laboratory Notebooks (ELNs), Chromatography Data Systems (CDS), and Scientific Data Management Systems(SDMS).NOTE 1Laboratory informatics scope encompasses multiple technical solutions or systems. The d

11、ivision between these system categories continuesto soften as functionality continues to be added to each of them. LIMS were originally created to address the laboratories need to manage laboratoryoperations and data, provide traceability for all laboratory samples and equipment, and ensure that lab

12、oratory procedures are followed. ELNs, on the otherhand, were originally created to meet the scientistsneed to document their experimental design, execution, and conclusions in an electronic format insteadof in a paper notebook. SDMS was created to provide a repository of all scientific data files a

13、nd results regardless of instrument type. The currentdefinitions of each of these system categories are far more encompassing.1.4 Scope Considerations When Selecting and Implementing Laboratory Informatics SolutionsMany laboratories havedetermined that they need to deploy multiple laboratory informa

14、tics systems to automate their laboratory process and manage theirdata. Selection of an informatics solution requires a detailed analysis of the laboratorys requirements rather than by choosing aproduct category. It is important to include representatives from Information Technology (IT) and Subject

15、 Matter Experts (SMEs),who understand the needs of the laboratory, to be involved in the selection and implementation of a laboratory informatics systemto ensure that the needs of the laboratory are met and that IT can support it. Customers (internal and external) of laboratoryinformation should als

16、o be included in the laboratory informatics solution design, to ensure there is full electronic integrationbetween systems.1 This guide is under the jurisdiction ofASTM Committee E13 on Molecular Spectroscopy and Separation Science and is the direct responsibility of Subcommittee E13.15on Analytical

17、 Data.Current edition approved Sept. 1, 2006Aug. 1, 2013. Published September 2006November 2013. Originally approved in 1993. Last previous edition approved in 19992006as E1578 93 (1999).E1578-06. DOI: 10.1520/E1578-06. 10.1520/E1578-13.This document is not an ASTM standard and is intended only to p

18、rovide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof t

19、he standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States11.5 Laboratory CategoriesThe spectrum of laboratories that employ LIMS is wide spread. The following break down

20、provides an overview of the laboratory categories that use LIMS as well as examples of laboratories in each category.scope of thisguide covers a wide range of laboratory types, industries, and sizes. Examples of laboratory types and industries are listed in thefollowing:1.5.1 General Laboratories:1.

21、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, and1.4.3.2 Diagnostic,1.4.3.3 Healthcare Medical,1.4.3.4 Devices, and1.5.3.2 Pharmaceuticals Vet

22、/Animal.Diagnostic.1.5.4 Healthcare Medical:1.5.4.1 Devices,1.5.4.2 Pharmaceuticals vet/animal,1.5.4.3 Public health, and1.5.4.4 Hospital LIS.1.5.5 Heavy Industry Laboratories:1.5.5.1 Energy 40 FR 3210D, Jan. 20, 1975FDACFR Part 50,Appendix E 10 10 Code of Federal Regulations (CFR) Part 50Appendix E

23、. 45 FR 55410,Aug. 19, 1980Aug.19, 1980, , et sequentia as amendedFDA CFR Part 50, Appendix K 10 10 Code of Federal Regulations (CFR) Part 50 Appendix K. 21 FR 355, Jan. 19, 1956Jan.19, 1956, , unless otherwise noted3. Terminology3.1 This guide defines the majority of different terminology used in t

24、he LIMS field. Sectionlaboratory informatics tools 3.2defines LIMS terms specific to this guide. field. Users of this documentguide should request a terminology list from each vendorwith a cross reference to the terms used in this guide.3.2 Definitions of Terms Specific to This Standard:3.2.1 CAPA,

25、nacronym for corrective action, preventative action.3.2.1 Chromatography Data System (CDS),chromatography data system, CDS, ncomputer system used to acquire, analyze,store, and report information from chromatography instruments.chromatographs.3.2.2 cloud computing, vterm generally used to refer to s

26、oftware applications that are delivered as a software service throughremote hosting using the public internet (public cloud) or within the users network environment (private cloud).3.2.2.1 DiscussionEssentially, the difference between cloud computing and a traditional application deployment is that

27、the application users are notresponsible for the installation and maintenance of the computing infrastructure and application software.6 Available from International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH Secretariat, c/oIFP

28、MA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20, Switzerland, http:/www.ich.org.7 Available from Institute of Electrical and Electronics Engineers, Inc. (IEEE), 445 Hoes Ln., P.O. Box 1331, Piscataway, NJ 08854-1331,08854, http:/www.ieee.org.8 Available from International Organization for Stan

29、dardization (ISO), 1, ch. de la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http:/www.iso.org.9 Available from U. S. Nuclear Regulatory Commission (NRC), One White Flint North, 11555 Rockville Pk., Rockville, MD 20852-2738, http:/www.nrc.gov.E1578 1343.2.3 corrective and preventative action,

30、 CAPA, nCAPA applications are used to collect information, analyze information,identify and investigate product and quality problems, and take appropriate and effective corrective or preventive or both actionto prevent their recurrence.3.2.3.1 DiscussionVerifying or validating corrective and prevent

31、ive actions, communicating corrective and preventive action activities to responsiblepeople, providing relevant information for management review and documenting these activities are essential in dealing effectivelywith product and quality problems, preventing their recurrence, and preventing or min

32、imizing device failures.103.2.4 data exchange standardization, nas defined by the International Organization for Standardization (ISO) in ISO/HL727932, the process of agreeing on standards, which represent the common language that allows the exchange of data betweendisparate data systems.3.2.4.1 Dis

33、cussionThe goals of standardization are to achieve comparability, compatibility, and interoperability between independent systems, toensure compatibility of data for comparative statistical purposes, and to reduce duplication of effort and redundancies. A datastandard often includes data elements, d

34、ata element definitions, and such agreements as formats, message structures, vocabulary.In the context of this paper, a standard is a specification or requirement and is not synonymous with a policy, procedure, guideline,framework, technique, or best practice. Adopting standards has the potential to

35、 improve interoperability and reduce costs byfacilitating the ability of networked laboratories to coordinate activities during public health incidents where surge capacity maybe required (for example, national response and readiness).Adopting standards may reduce the costs of LIMS implementation an

36、dvendor/developer support.3.2.5 electronic document management system, EDMS, nacronym for electronic document management system.used to store,catalog retrieve, view, and print digital documents.3.2.5.1 DiscussionModern EDMS applications typically provide the ability to manage a document throughout i

37、ts lifecycle with functions includingdocument initiation, multiple levels of review, version controls, security and archive of historical versions of documents.3.2.6 electronic laboratory notebook, ELN, nacronym for electronic laboratory notebook. computer system software programdesigned to replace

38、paper laboratory notebooks. Defined by CENSA (Collaborative Electronic Notebook Systems Association) as“a system to create, store, retrieve, and share fully electronic records in ways that meet all legal, regulatory, technical and scientificrequirements.”3.2.6.1 DiscussionLabLaboratory notebooks in

39、general are used by scientists scientists, engineers, and technicians to document research,experiments, and procedures performed in a laboratory. A lablaboratory notebook is often maintained to be a legal document andmay be used in a court of law as evidence. Similar to an inventors notebook, the la

40、blaboratory notebook is also often referred toin patent prosecution and intellectual property litigation. Electronic laboratory notebooks enable electronic access to informationincluding searching, data capture from instruments and collaboration between laboratory personnel and personnel outside the

41、laboratory.3.2.4.2 DiscussionELNs can be divided into two categories: specific ELNs contain features designed to work with specific applications, scientificinstrumentation or data types. Refer to laboratory exectuion system (LES) as an example of a specific ELN. Cross-disciplinaryELNs or generic ELN

42、s are designed to support access to all data and information that needs to be recorded in a lab notebook.3.2.7 enterprise resource planning, ERP, nacronym for enterprise resource planning.ERP system integrates different types ofdata such as inventory levels, product orders, accounting, manufacturing

43、 capacity, inspection results, and customer relationshipmanagement information from organizations within an enterprise (company) to facilitate the flow of information between variousbusiness functions across a company as well as with outside business partners.10 For additional information, visit htt

44、p:/www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170612.htm#page1.E1578 1353.2.8 GALP, good automated manufacturing practice forum, GAMP Forum, nthe GALPs are a union of federal regulations,policies, and guidance documents. Several of the GALP provisions are embodied in EPAs Good Laboratory Prac

45、tice Standards(GLPs). The GLPs are regulations that govern the management and conduct of most nonclinical laboratory studies submitted toEPAs office of Toxic Substances and its Office of Pesticide Programs. Reference EPA 2185.a volunteer group under the auspicesof the International Society of Pharma

46、ceutical Engineering (ISPE) for writing guidance for the validation of computerized systemsused in the regulated portions of the pharmaceutical and allied industries. It is specifically designed to aid suppliers and users inthe pharmaceutical industry.3.2.9 integration broker, nmessaging application

47、 that can receive or extract data from a source system at the appropriate time,transform the data, and route the reformatted data to the target node.3.2.9.1 DiscussionAn integration broker application can also provide a repository for archiving, searching, and retrieving these messages.3.2.10 GAMP,

48、laboratory information system, LIS, nacronym for good automated manufacturing practice.class of applicationsoftware that supports clinical laboratories by helping technologists manage the quality and integrity of test samples; departmentalworkflow functions, result review processes, reporting of fin

49、alized results, interpretations, and diagnosis.3.2.10.1 DiscussionThese systems often interface with instruments and other information systems such as hospital information systems (HIS). A LISis a highly configurable application and often includes laboratory-specific electronic medical records; direct clinician access viasecure web connections; billing modules for laboratories performing commercial testing; sophisticated interface engines forrouting orders and results to external systems; and on-board image archival systems for pathology images