ASTM_E_2066_-_00_2007.pdf

Designation:E206600(Reapproved 2007)Standard Guide forValidation of Laboratory Information Management Systems1This standard is issued under the fixed designation E2066;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 describes an approach to the validationprocess for a Laboratory Information Management System(LIMS).1.2 This guide is for validation of a commercial LIMSpurchased from a vendor.The procedures may apply to othertypes of systems,but this guide makes no claim to address allissues for other types of systems.Further,in-house developedLIMS,that is,those developed by internal or external program-mers specifically for an organization,can utilize this guide.Itshould be noted that there are a number of related softwaredevelopment issues that this guide does not address.Users whoembark on developing a LIMS either internally or with externalprogrammers also should consult the appropriate ASTM,ISO,and IEEE software development standards.1.3 This guide is intended to educate individuals on LIMSvalidation,to provide standard terminology useful in discus-sions with independent validation consultants,and to provideguidance for development of validation plans,test plans,required standard operating procedures,and the final validationreport.2.Referenced Documents2.1 ASTM Standards:2E622 Guide for Developing Computerized Systems(Discon-tinued 2000)(Withdrawn 2000)3E623 Guide for Developing Functional Requirements forComputerized Systems(Withdrawn 1994)3E624 Guide for Developing Implemention Designs for Com-puterized Systems(Withdrawn 1994)3E627 Guide for Documenting Computerized Systems(Dis-continued 2000)(Withdrawn 2000)3E919 Specification for Software Documentation for a Com-puterized System(Discontinued 2000)(Withdrawn 2000)3E1013 Terminology Relating to Computerized Systems(Withdrawn 2000)3E1384 Practice for Content and Structure of the ElectronicHealth Record(EHR)E1578 Guide for Laboratory InformaticsE1639 Guide for Functional Requirements of Clinical Labo-ratory Information Management Systems(Withdrawn2002)32.2 IEEE Standards:4100 Standard Dictionary of Electric and Electronic Terms610 Standard Glossaries of Computer-Related Terminology729 Glossary of Software Engineering Terminology730.1 Standard for Software Quality Assurance Plans730.2 Guide for Software Quality Assurance Plans828 Standard for Software Configuration Management Plans829 Standard for Software Testing Documentation830 Guide for Software Test Documentation1008 Standard for Software Unit Testing1012 Standard for Software Verification and Validation Plans1016 Recommended Practice for Software Design Descrip-tions1028 Standard for Software Reviews and Audits1042 Guide to Software Configuration Management1058-1 Standard for Software Project Management Plans1063 Standard for Software User Documentation1074 Standard for Developing Software Life Cycle Pro-cesses1228 Standard for Software Safety Plans2.3 ISO Standards:59000 Quality Management and Quality Assurance Standards-Guidelines for Selection and Use9000-3 Guidelines for Application of ISO 9001 toDevelopment,Supply,and Maintenance of Software9001 Quality SystemsModel for Quality Assurance inDesign,Production,Installation,and Servicing9002 Quality SystemsModel for Quality Assurance inProduction and Installation1This 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 March 1,2007.Published March 2007.Originallyapproved in 2000.Last previous edition approved in 2000 as E2066 00.DOI:10.1520/E2066-00R07.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at 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 Institute of Electrical and Electronics Engineers,Inc.(IEEE),445 Hoes Ln.,P.O.Box 1331,Piscataway,NJ 08854-1331,http:/www.ieee.org.5Available from International Organization for Standardization(ISO),1 rue deVaremb,Case postale 56,CH-1211,Geneva 20,Switzerland,http:/www.iso.ch.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 9003 Quality SystemsModel for Quality Assurance inFinal Inspection and Test9004 Quality Management and Quality System ElementsGuidelines9004-2 Quality Management and Quality System Elements,Part 2 Guidelines for Services9004-4 Guidelines for Quality Improvements10005 Guidelines for Quality Plans10007 Guidelines for Configuration Management10011-1 Guidelines for Auditing Quality System