欢迎您注册蒲公英
您需要 登录 才可以下载或查看，没有帐号？立即注册
x
ISPE GAMP® Records and Data Integrity Guide
Disclaimer: 免责声明 This Guide is intended toassist regulatedcompanies in managing records and data throughout the data life cycle. ISPEcannot ensure and does not warrant that a system managed in accordance withthis Guide will be acceptable to regulatory authorities. Further, this Guidedoes not replace the need forhiring professional engineers or technicians. 本指南旨在协助受监管公司在数据生命周期中的记录和数据方面过的管理。ISPE不能够确保和保证按照本指南管理的系统也符合监管部门的要求。而且，本指南也不能取代雇佣专业工程师或技术人员的需求。 Limitation of Liability 有限责任 In noevent shall ISPE or any of its affiliates, or the officers, directors,employees, members, or agents of each of them,or the authors, be liable for any damages of any kind, including withoutlimitation any special, incidental, indirect, or consequential damages, whetheror not advised of the possibility of such damages, and on any theory ofliability whatsoever, arising out of or in connection with the use of thisinformation. 在任何情况下，国际制药工程协会(简称:ISPE)或其附属机构，或其官员、理事、工作人员、会员或他们的任何代理人都不对发生的任何损害承担责任，包括特殊的、偶然的、间接的损害，不管他们是否已经被告知这些损害发生的可能性，且无论责任是否由使用这本指南的信息所引起。 © Copyright ISPE 2017. All rightsreserved. 版权归ISPE2017所有。保留所有版权。 All rights reserved. No part ofthis document may be reproduced or copied in any form or by any means –graphic, electronic, or mechanical, including photocopying, taping, orinformation storage and retrieval systems – without written permission of ISPE. 保留所有版权。在没有ISPE 书面许可的情况下，不得对本指南的任何部分以任何形式或方法进行复制——文字的、电子的或机械的，包括拍照、录音，及信息存储与检索系统。 All trademarks used areacknowledged. 所有使用的商标均被认可。 ISBN 978-1-936379-96-5 国际标准图书标号978-1-936379-96-5
Preface 前言 The importance of data integrityis reflected in recent guidance, citations, and public comments of Regulatorsand Health Agencies. A number of companies have suffered serious regulatory andfinancial consequences as a result of unacceptable data integrity practices. 数据完整性的重要性体现在监管机构和卫生机构最近的指导、引用和公开评论中。由于无法接受的数据完整性实践，许多公司遭受了严重的监管和财务后果。 Patient safety is affected by theintegrity of critical records, data, and decisions, as well as those aspects concernedwithphysical attributes of the product. That the phrase “patient safety,product quality, and data integrity” is commonly used in regulatory andindustry guidance underlines this point. 患者安全受到关键记录、数据和决策的完整性以及与产品物理属性相关的方面的影响。“患者安全、产品质量和数据的完整性”这句话经常被用于监管和行业指导中。 The use of information technologyand computerized systems in all aspects of life sciences continues to grow andhas resulted in the generation of more data to support the development andmanufacture of products. Key decisions and actions are routinely being madebased on this data, and the integrity of the data, whether in electronic orpaper form, is of paramount importance to the industry, the regulatory agencies,and ultimately the patient. 信息技术IT和计算机化系统CS在生命科学各个方面的应用不断增长，并产生了更多的数据来支持产品的开发和制造。关键的决定和行动通常是根据这些数据做出的，而数据的完整性，无论是电子还是纸质形式，对行业、监管机构以及最终的患者来说都是至关重要的。 Industry will benefit from clearguidance on ensuring that the management of records and data forms an integral partof the Quality Management System, and is compliant with GxP requirements. ThisGuide intends to provide such guidance and is aligned with ISPE GAMP® 5: ARisk-Based Approach to Compliant GxP Computerized Systems. 行业将从明确的指导中获益，确保记录和数据表格的管理是质量管理系统的组成部分，并符合GxP的要求。本指南意图提供这样的指导，并与ISPEGAMP5: GxP计算机化系统的基于风险的方法保持一致。
Acknowledgements 致谢 The ISPE GAMP® Records and DataIntegrity Guide was produced by a Task Team led by: The work was supported by theISPE GAMP Community of Practice (CoP). CoreTeam 核心团队 The following individuals tooklead roles in the preparation of this Guide: RegulatoryInput and Review 监管机构的意见和审查 Particular thanks go to thefollowing for their review and comments on this Guide: SubjectMatter Expert Input and Review 主题专家的意见和审查 Particular thanks go to thefollowing for their review and comments on this Guide: The Team would like to specialthanks to the Global GAMP Data Integrity Special Interest Group (SIG) for theirefforts. The Team Leads would like toexpress their grateful thanks to the many individuals and companies from aroundthe world who reviewed and provided comments during the preparation of thisGuide; although they are too numerous to list here, their input is greatlyappreciated. Company affiliations are as ofthe final draft of the Guide.
Tableof Contents 1Introduction介绍 1.1 Background背景 1.2 Purpose目的 1.3 Scope范围 1.4 Structure of thisGuide本指南的结构 1.5 Key Concepts关键概念 1.6 KeyTerms关键术语
2Regulatory Focus监管重点 2.1 Introduction介绍 2.2 Data IntegrityRequirements数据完整性的要求
3Data Governance Framework数据管理框架 3.1 Introduction介绍 3.2 Overview综述 3.3 Elements of theData Governance Framework数据管理框架的元素 3.4 Human Factors inData Integrity数据完整性中的人为因素 3.5 Data Integrity MaturityModel数据完整性成熟模型
4 Data Life Cycle数据生命周期 4.1 Introduction介绍 4.2 Data Creation数据的产生 4.3 Data Processing数据的处理 4.4 Data ReviewReporting and Use数据审查报告和使用 4.5 Data Retention andRetrieval数据的存储和检索 4.6 Data Destruction数据的销毁
5Quality Risk Management质量风险管理 5.1 Introduction介绍 5.2 Process RiskAssessment过程风险评估 5.3 Quality RiskManagement Approach质量风险管理方法 5.4 Product and ProcessContext产品和工艺处境
Management Appendices 6 Appendix M1 –Corporate Data Integrity Program公司数据完整性程序 6.1 Introduction 介绍 6.2 Is a Corporate DataIntegrity Program Required? 公司是否需要数据完整性程序? 6.3 Indicators ofProgram Scope and Effort计划的范围和成果的指标 6.4 ImplementationConsiderations实施的注意事项 6.5 Keys to Success成功的关键 7 Appendix M2 – DataIntegrity Maturity Model数据完整性成熟度模型 7.1 Maturity Model成熟度模型 7.2 Data IntegrityMaturity Level Characterization数据完整性成熟度级别描述 8 Appendix M3 – HumanFactors人为因素 8.1 Introduction介绍 8.2 Corporate and LocalCultures企业及本地文化 8.3 Classification ofIncidents事件的分类 8.4 Human Error人为误差 8.5 Data Falsificationand Fraud数据伪造和欺诈 8.6 Impartiality追求公正 8.7 Behavioral Controls行为控制 9 Appendix M4 – DataAudit Trail and Audit Trail Review数据审计追踪和审计追踪审核 9.1 Introduction介绍 9.2 RegulatoryBackground监管的背景 9.3 Application and Useof Audit Trails审计追踪的应用和使用 9.4 Audit Trail Review审计追踪审核 9.5 Technical Aspectsand System Design技术因素和系统设计 10 Appendix M5 – DataAuditing and Periodic Review资料审核及定期检查 10.1 Introduction介绍 10.2 Auditing for DataIntegrity数据完整性审计 10.3 Periodic Review定期检查 10.4 Other Reviews其他检查 10.5 Documenting ReviewProcesses记录评审过程 11 Appendix M6 –Inspection Readiness检查准备 11.1 General Procedures通用程序 11.2 Key Informationfor Regulatory Inspections监管检查的关键信息 12 Appendix M7 –Integrating Data Integrity into Existing Records Management Processes将数据完整性整合到现有的记录管理流程中 12.1 Introduction介绍 12.2 Record Creation记录的创建 12.3 Active Records主动记录 12.4 Semi-activeRecords半主动记录 12.5 Inactive Records非主动记录 Development Appendices
13 Appendix D1 – UserRequirements用户需求 13.1 Introduction介绍 13.2Business Process业务流程 13.3 General Data IntegrityRequirements一般数据完整性的要求 14 Appendix D2 –Process Mapping and Interfaces流程映射和接口 14.1 Introduction介绍 14.2 Process Flowcharts过程流程图 14.3 Data Flow Diagrams数据流图 14.4 How Much IsNeeded? 需要多少? 15 Appendix D3 – RiskControl Measures for Records, Data, and Electronic Signatures记录、数据和电子签名的风险控制措施 15.1 Introduction介绍 15.2 Record and DataControls记录和数据控制 15.3 ElectronicSignature Controls电子签名控制 15.4 Implementation ofRecord and Data Controls记录和数据控制的实施 15.5 Rigor of Controls严格的控制 16 Appendix D4 – DataIntegrity Concerns Related to System Architecture与系统架构相关的数据完整性问题 16.1 Data Resides on aLocal Hard Disk数据驻留在本地硬盘上 16.2 Internally ManagedCentral Database内部管理的中央数据库 16.3 Internally ManagedDistributed Data内部管理的分布式数据 16.4 Outsourced ManagedServices外包管理服务 17 Appendix D5 – DataIntegrity for End-User Applications终端用户应用程序的数据完整性 17.1 Introduction介绍 17.2 Data Integrity forSpreadsheets电子表格的数据完整性 17.3 Data Integrity forPC DatabasesPC数据库的数据完整性 17.4 Data Integrity forStatistical Tools统计工具的数据完整性 Operation Appendices
18 Appendix O1 –Retention, Archiving, and Migration保留、归档和迁移 18.1 Introduction介绍 18.2 Retention Options保留选项 18.3 Protection ofRecords记录保护 18.4 Record Aging andRisk记录的老化和风险 18.5 Archival归档 18.6 Hybrid Situationsand Archives混合情况和归档 18.7 Audit Trail Considerations审计跟踪事项 18.8 AlternativeSystems替代性制度 18.9 ConvertingElectronic to Alternative Format or Alternative Media Hybrids转换电子到可替代格式或替代媒体的混合记录 19 Appendix O2 – PaperRecords and Hybrid Situations纸张记录和混合情况 19.1 Paper Records纸张记录 19.2 Hybrid Situations混合情况 19.3 Use of Forms toEnforce Procedures使用表格执行程序 General Appendices
20 Appendix G1 –References参考文献 21 Appendix G2 –Glossary术语 21.1 Acronyms andAbbreviations首字母缩写词和缩写词 21.2 Definitions定义
本文转自微信公众号：分析实验室 AnalyticalLab，陆续更新中......
| 
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2019-6-10 21:42:44
置顶卡
变色卡
