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ISPE推出新指南： GAMP RDI Good Practice Guide: Data Integrity - Key Concepts GAMP RDI优良规范指南：数据完整性--关键概念
先上官方图一张 
对，你没看错，就是这么贵------会员价160美刀=133欧，非会员价350美刀=292欧，当然，还有特殊地区价格，不过作为自豪的中国人，我们好像不属于。 我知道你一定是下面这个样子
为了勾引大家买，官方自然是要一如往常地放出TOC（目录）来让大家蓝瘦香菇一下了，官方TOC的PDF下载链接如下哈 https:///sites/default/files/publications/manuals/GAMP_RDIGPG1-DICON_TOC.pdf
ISPE大概是想说 
具体介绍如下 Published:October 2018
Pages: 196
Bound version ships after 26 October 2018 The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts provides detailed practical guidance to support dataintegrity within a regulated organization. In recent years significant problems with data integrity have been found in the pharmaceutical, biotechnology, and medical device industries worldwide. This ultimately affects patients, as patient safety is intrinsically impacted by the integrity and quality of the data on which aregulatory decision is based. Additionally, the implementation of behavioral, procedural, and technical solutions to meet regulatory requirements throughout the business process proves to be challenging for organizations that do not have expertise in incorporating data integrity into their daily activities. This Guide integrates tools such as Cultural Excellenceand critical thinking skills into data integrity practices to aid companies in meeting regulatory requirements and expectations. Numerous examples of good data integrity practices along with ways to identify risks and detect issues are included to assist organizations in developing or raising their data integrity awareness. This Guide is positioned under the ISPE GAMP®Guide: Records and Data Integrity and is aligned with ISPE GAMP® 5:A Risk-Based Approach to Compliant GxP Computerized Systems. 出版日期：2018年10月 页数：196 该指南为受法规管理的组织内的数据完整性提供详细的实践指南支持。 最年，在全球药业、生物技术与医疗器械行业发现严重的数据完整性问题。这最终会对患者产生影响，因为患者安全从本质上讲会受到数据完整性与质量影响，这是药监机构决策的根本所在。 另外，实施行为、程序和技术解决方案以在整个业务流程中符合药监机构的要求，对于没有将数据完整性整合至其日常活动的专家的组织来说，是相当具有挑战性的。 本指南结合了如文化卓越和批判性思维技巧工具到数据完整性规范中，帮助公司符合法规要求和期望。在其中放入了大量优良数据完整性规范的例子与识别风险和发现问题的方法，用以帮助企业建立或提升其数据完整性意识。 本指南放在“ISPE GAMP指南：记录与数据完整性”（2017年3月）下面，与“ISPEGAMP5：基于风险的GXP计算机化系统合规方法”（2008年2月）相一致。 ISPE官方订购页面：https:///publications/guidance-documents/gamp-good-practice-guide-date-integrity-key-concepts
不要问本宫有没有，我也很无奈，因为我也--木--有--钱 
不过目录还有可以免费看一看的，这个是可以有哈
1 | Introduction | 前言 | 1.1 | Background | 背景 | 1.2 | Purpose | 目的 | 1.3 | Scope | 范围 | 1.4 | Structure of This Guide | 本指南结构 | 2 | Data Governance | 数据管理 | 2.1 | Data Integrity Culture | 数据完整性文化 | 2.2 | Roles and Responsibilities | 角色与职责 | 2.3 | Good Documentation Management Practices | 优良文件管理规范 | 2.4 | Data Classification | 数据分类 | 2.5 | Gap Assessments as Part of a Corporate Data Integrity Program | 差距分析作为公司数据完整性计划 | 3 | Data Life Cycle | 数据生命周期 | 3.1 | Data Definitions and Requirements | 数据定义与要求 | 3.2 | Data and System Life Cycle Interrelationships | 数据与系统生命周期诠释 | 4 | Risk Management Approaches | 风险管理方法 | 4.1 | Focus of Risk Management | 关注风险管理 | 4.2 | Supplier and Third-Party Management | 供应商与第三方管理 | 4.3 | GxP Computerized Systems | GXP计算机化系统 | 4.4 | System Interfaces | 系统接口 | 4.5 | Access Controls | 访问控制 | 5 | Critical Thinking | 批判性思维 | 5.1 | Auditing | 审计 | 5.2 | Use of Analytics to Detect Data Integrity Issues | 使用分析发现数据完整性问题 | 6 | Appendix 1 – Data Integrity Gemba Checklist in the Laboratory | 附录1-化验室数据完整性现场检查清单 | 7 | Appendix 2 – IMPACT Tool Applied to Data Integrity | 附录2- 应用IMPACT工具于数据完整性 | 8 | Appendix 3 – Corporate Data Integrity Program Case Study | 附录3-公司数据完整性计划安全研究 | 8.1 | Background | 背景 | 8.2 | Program Objectives | 计划目的 | 8.3 | Governance | 管理 | 8.4 | Program Action Plan | 行动计划 | 8.5 | Conclusion | 结论 | 9 | Appendix 4 – Culture and Continuous Improvement Capability Road Map | 附录4-文件与持续改进能力路线图 | 10 | Appendix 5 – Regulatory Definitions of Data Terminology | 附录5-数据术语的法规定义 | 11 | Appendix 6 – Requirements Planning | 附录6-需求规划 | 11.1 | Introduction | 前言 | 11.2 | Requirements | 需求 | 11.3 | Requirements Analysis | 需求分析 | 12 | Appendix 7 – Requirements Specification and Data Integrity Risks for Interfaces | 附录7-需求说明与接口的数据完整性风险 | 12.1 | Interface Requirements Specification | 接口需求说明 | 12.2 | Typical Data Integrity Issues Related to Data Interfaces | 与数据接口有关的典型的数据完整性问题 | 13 | Appendix 8 – Example of a Four-Tier Classification System of a Life Science Company | 附录8-生命科学公司的四层分类系统举例 | 14 | Appendix 9 – Security Controls | 附录9-安全控制 | 14.1 | Security Controls | 安全控制 | 14.2 | Review of Controls | 控制审核 | 15 | Appendix 10 – Case Study: DBA and Security Controls for an RTSM System in a GCP Environment | 附录10-案例研究：GCP环境中的RTSM系统DBA与安全控制 | 15.1 | Background | 背景 | 15.2 | Infrastructure Controls | 硬件设施控制 | 15.3 | Account Controls | 账号控制 | 15.4 | Segregation of Duties | 任务划分 | 15.5 | Periodic Reviews | 定期审核 | 15.6 | Internal Audit | 内审 | 16 | Appendix 11 – Case Study: DBA and Security Controls for an ERP System in a Medical Device Manufacturing Environment | 附录11-案例研究：医疗器械生产环境中的ERP系统DBA与安全控制 | 17 | Appendix 12 – Case Study: Laboratory Computerized System | 附录12-案例研究：实验室计算机化系统 | 17.1 | Typical Use Scenario | 一般应用情形 | 17.2 | Records Risk Assessment and Controls Considerations | 记录风险评估与控制考量 | 17.3 | CDS Example | CDS举例 | 17.4 | Remediation Plan | 补救计划 | 18 | Appendix 13 – Case Study: Uncontrolled Spreadsheet | 附录13-案例研究：不受控的计算表格 | 18.1 | Scenario | 情景 | 18.2 | Records Risk Assessment and Controls Considerations | 记录风险评估与控制考量 | 18.3 | Spreadsheet Example | 计算表举例 | 18.4 | Remediation Plan | 补救计划 | 19 | Appendix 14 – Case Study: Process Control System | 附录14-案例研究：工艺控制系统 | 19.1 | Scenario | 情景 | 19.2 | Records Risk Assessment and Controls Considerations | 记录风险评估与控制考量 | 19.3 | PCS Example | PCS举例 | 19.4 | Remediation Plan | 补救计划 | 20 | Appendix 15 – Case Study: Business Application System | 附录15-案例研究：业务应用系统 | 20.1 | Scenario | 情景 | 20.2 | Records Risk Assessment and Controls Considerations | 记录风险评估与控制考量 | 20.3 | IT Systems Example | IT系统举例 | 20.4 | Remediation Plan | 补救计划 | 21 | Appendix 16 – Reviewing Laboratory Systems | 附录16-审核化验室系统 | 21.1 | General Requirements | 通用要求 | 21.2 | Access Roster Review | 访问名单审核 | 21.3 | Data and Transfers | 数据与转移 | 21.4 | Data Processing | 数据处理 | 21.5 | Laboratory System Audit Trails | 实验室系统审计追踪 | 22 | Appendix 17 – Reviewing IT Systems | 附录17-审核IT系统 | 22.1 | IT System Overview | IT系统概览 | 22.2 | User Access | 用户权限 | 22.3 | IT Audit Trails | IT审计追踪 | 22.4 | IT System Validation | IT系统验证 | 22.5 | IT System Data Flow | IT系统数据流 | 22.6 | IT System Data Storage | IT系统数据存贮 | 23 | Appendix 18 – Reviewing Supporting Data | 附嫌18-审核支持性数据 | 23.1 | Time card or Badge-in vs. Data or Batch Approval | 时间卡与身份卡VS数据或批批准 | 23.2 | Maintenance Records vs. Data in Historian | 保存记录VS历史库内数据 | 23.3 | Batch Records vs. Component or Material Records | 批记录VS组份或物料记录 | 23.4 | Concealing Things in a Parallel System: The Numbers Game | 平行系统中的隐藏事件：数字游戏 | 23.5 | Timing: Determining the Real Sequence of Events | 计时：确定事件的实时序列 | 24 | Appendix 19 – Auditing Access Controls | 附录19-审计访问控制 | 25 | Appendix 20 – Regulatory Guidance Regarding Classification of Deficiencies | 附录20-关于缺陷分类的法规指南 | 26 | Appendix 21 – Detecting Aberrant Results | 附录21-发现异常结果 | 26.1 | Detection Methods | 发现方法 | 26.2 | Assumptions | 假设 | 26.3 | Grouping, Normalizing, and Profiling Data | 数据分组、正常化与特点分析 | 27 | Appendix 22 – References | 附录22-参考文献 | 28 | Appendix 23 – Glossary | 附录23-术语 | 28.1 | Abbreviations and Acronyms | 缩略语与同义词 | 28.2 | Definitions | 定义 |
拿着这个目录，大家可以考虑说服你们的老大买一本，这个真的可以有 
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