经合组织关于良好实验室规范和信息技术安全的立场文件

Series on Principles of Good Laboratory Practiceand Compliance MonitoringNo.25 Series onPrinciples of Good Laboratory Practice and Compliance MonitoringNo. 25 OECD Position Paper on Good LaboratoryPractice and IT Security Pleasecitethispublicationas: OECD (2024),OECD Position Paper on Good Laboratory Practice and IT Security, OECD Serieson Principles of GoodLaboratory Practice and Compliance Monitoring, No.25, OECD Publishing, Paris. © OECD 2024 Attribution 4.0International (CC BY 4.0) This work is made available under the Creative Commons Attribution 4.0 International licence. By using this work, you acceptto be bound by the terms of thislicence (https://creativecommons.org/licenses/by/4.0/). Attribution–you must cite the work.Translations–you must cite the original work, identify changes to the original and add the following text:In the event of any discrepancy between the originalwork and the translation, only the text of original work should be considered valid.Adaptations–you must cite the original work and add the following text:This is an adaptation of an original work by the OECD. The opinions expressed andarguments employed in this adaptation should not be reported as representing the official views of the OECD or of its Membercountries.Third-party material–the licence does not apply to third-party material in the work. If using such material, you are responsible for obtaining permission fromthe third party and for any claims of infringement.You must not use the OECD logo, visual identity or cover image without express permission or suggest the OECD endorses your use of the work.Any dispute arising under this licence shall be settled by arbitration in accordance with the Permanent Court of Arbitration(PCA) Arbitration Rules 2012. Theseat of arbitration shall be Paris (France). The number of arbitrators shall be one. About the OECD TheOrganisation forEconomicCo-operation and Development(OECD)isanintergovernmental organisation in which representatives of 38 countries in North and SouthAmerica, Europe and the Asia and Pacific region, as well as the EuropeanUnion, meet to co-ordinate and harmonise policies, discuss issues of mutual concern, and work together torespond to international problems. Most of the OECD’s work is carried out by more than 200specialisedcommittees and working groups composed of member country delegates.Observers from severalPartnercountries and from interested international organisations attendmany of the OECD’s workshops and other meetings. Committees and working groups areserved by the OECD Secretariat, located in Paris, France, which is organised into directoratesand divisions. The Environment, Health and Safety Division publishes free-of-charge documents in twelvedifferent series:Testing and Assessment;Good Laboratory Practice and ComplianceMonitoring;Pesticides;Biocides;Risk Management;Harmonisation of RegulatoryOversight in Biotechnology;Safety of Novel Foods and Feeds; Chemical Accidents;Pollutant Release and Transfer Registers; Emission Scenario Documents; Safety ofManufactured Nanomaterials;andAdverse Outcome Pathways.More information about theEnvironment, Health and Safety Programme and EHS publications is available on the OECD’sWorld Wide Web site (https://www.oecd.org/en/topics/chemical-safety-and-biosafety.html). This publication was developed in the IOMC context. The contents do not necessarilyreflect the views or stated policies of individual IOMC Participating Organizations. The Inter-Organisation Programme for the Sound Management of Chemicals (IOMC)was established in 1995 following recommendations made by the 1992 UN Conferenceon Environment andDevelopment to strengthen co-operation and increase internationalco-ordination in the field of chemical safety. The Participating Organisations are FAO,ILO,UNDP,UNEP,UNIDO,UNITAR,WHO,World Bank,Basel,Rotterdam andStockholm Conventionsand OECD. The purpose of the IOMC is to promote co-ordinationof the policies and activities pursued by the Participating Organisations, jointly orseparately, to achieve the sound management of chemicals in relation to human healthand the environment. Foreword Thisposition paperwas developed by the OECD Working Party on Good Laboratory Practice(GLP)via a drafting group led by Denmark (Medical Products) and consisting of Austria,Belgium, Canada, France (Medical Products), Germany and Switzerland. The document drawsupon a publication developed on cyber security and Good Clinical Practice (GCP) at thelevelof theEuropean Union.The document was reviewed and endorsement by the Working Partyon Good Laboratory Practice. This document is published under the responsibility of theChemicals and Biotechnology Committee which agreed to its declassification. Table of contents About the OECD3 Foreword4 1. Introduction62. Scope63. Ongoing security measures and GLP responsibilities64. Physical security75. Firewalls76. Vulnerability management77. Platform Management88. Bidirectional devices (