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英文原版参见APIC官网，下载直链 https://apic./pub/Data_Integrity_Best_Practices_Guide_for_API_FINAL_March-2019.pdf 中英文对照点击阅读原文下载 链接：https://pan.baidu.com/s/1krFK5pt_ydPM26BxBonl7w 提取码：5zqk 由于该指南为实践指南，流程图和表格较多，部分表格原文为从EXCEL表格截图贴入，中英文中全部重新制表制图，与原文外貌差异处参见原文。 原文中有部分拼写错误，大部分明显者已纠正，小部分还涉及语法错误，未完全纠正。 以下为第一章内容 目录
1. General Section 通用部分 1.1 Introduction 简介 Dataintegrity refers to the accuracy, completeness and consistency of GxP data overits entire lifecycle. The steps that need to be overseen include the initialgeneration and recording, the processing (incl. analysis, transformation ormigration), the outcome/use, the retention, retrieval, archive and finally thedestruction. 数据完整性指GXP数据在其整个生命周期中的准确性、完整性和持续性。需要监管的步骤包括初始生成和记录、处理（包括分析、转化或迁移）、结果/使用、保存、检索、归档和最终销毁。 Dataintegrity means that all the steps defined above are well managed, controlledand documented and therefore the records of the activities follow the ALCOAprinciples described in the guidelines. 数据完整性意味着上述所有步骤均得到良好管理、控制和记录，因此活动的记录遵守本指南中所述的ALCOA原则。 TheALCOA and ALCOA principles have been in place for several years in theindustry and are widely known and implemented. Achieving data integritycompliance, for paper, electronic and hybrid systems, requires translation of these principles into practicalcontrols in order to assure GxP-impacting business decisions can be verified and inspected throughout the datalifecycle. ALCOA和ALCOA 原则在行业里已存在了数年，已得到广泛理解和执行。纸质、电子和混合系统达成数据完整性合规需要将这些原则转化为实用控制，以确保具GXP影响的业务决策可在其整个生命周期中得到确认和检查。 Currentlyavailable regulatory guidelines have been used to elaborate the approachoutlined in this practical guide (see also section 7, References). 目前已有的法规指南已被用来制订本实操指南中所列的方法（参见第7部分，参考文献）。 Thecurrent guidelines on data integrity require that companies complete dataintegrity criticality and risk assessments to ensure that the organizationaland technical controls that are put in place are commensurate with the level ofrisk to quality attributes. 当前对数据完整性的指南要求公司完成数据关键性和风险评估以确保所采用的组织和技术方面控制与质量属性风险水平相称。 Theguidelines emphasise the importance of creating and maintaining a workingenvironment and organisational culture that supports data integrity. Companiesshould establish data governance programs that address technical, proceduraland behavioural aspects to assure confidence in data quality and integrity. 指南强调了创建和维护支持数据完整性的工作环境和组织文件的重要性。公司应建立数据管理程序，从技术、程序和行为方面确保数据质量和完整性可信度。 Thisdocument will not describe all the elements required for a data governanceprogram in detail. However, some foundational principles are given below: 本文件不会详细讲解数据管理程序所需的所有要素，但也在下面列出了一些基本原则： · Organisational Culture 组织文化 Organisationalculture has the potential to increase the possibility for lapses in dataintegrity; intentional (e.g. fraud or falsification) or unintentional (e.g.lack of understanding of responsibilities and/or requirements). To reduce thispotential, organisations should aspire to an open culture where subordinatescan challenge hierarchy, and full reporting of a systemic or individual failureis a business expectation. 组织文化可能会有意（例如伪造或欺诈）或无意（例如缺乏对职责和/或需求的了解）地增加数据完整性出问题的可能性；。为降低这种可能性，组织应鼓励开放文化，下属可挑战等级制度，将全面地报告系统性或个人失败作为一项业务要求。 · Awareness 意识 Itis crucial that employees at all levels understand the importance of dataintegrity and the impact that they can have on GxP data with the authorisationsassigned for their job roles. Training is a major component of raisingawareness and should be conducted periodically. The ALCOA concepts, and theacronym itself, are widely used by regulators and industry and should beincorporated into the program (e.g. within staff training, policies etc.). 关键地的各层次员工了解数据完整性的重要性，及其对因工作原因获得授权的GXP数据可能产生的影响。培训是提升意识的主要组成部分，应定期进行。ALCOA 概念及缩写本身在药监机构和行业里被广泛使用，应整合至程序中（例如，放在员工培训、方针等内）。 · System and Process Design 系统和流程设计 Compliancewith data integrity principles can be encouraged through the consideration ofease of access, usability and location. For example: 可通过考虑易于获得、易用和位置来鼓励符合数据完整性原则： o Control over blank paper templates for GxPdata recording o 对GXP数据记录用空白纸质模板进行控制 o Control of spreadsheets used forcalculations o 对用于计算的表格进行控制 o Access to appropriate clocks for recordingtimed events o 可获得适当的时钟记录需要计时的事件 o Accessibility of records at the locationswhere activities take place o 在活动发生的地方可访问记录 o User access rights and permissions thatalign with personnel responsibilities o 用户访问权限和许可与人员职责相对应 o Automation of GxP data capture wherepossible o 尽可能自动捕获GXP数据 o Access to electronic GxP data for staffperforming data review activities o 为执行数据审核活动的员工提供电子GXP数据访问权限 · Management Commitment 管理者承诺 Seniormanagement should ensure that there is a written commitment to follow aneffective quality management system and professional practices to deliver gooddata management. The commitments should include 高级管理人员应确保有书面承诺来执行有效的质量管理体系，以及专业性做法来实现良好的数据管理。承诺应包括： · An open quality culture · 开放的质量文化 · Data integrity governance · 数据完整性管理 · Allocation of appropriate resources · 适当的资源配置 · Data integrity training for staff · 员工数据完整性培训 · Monitoring of data integrity issues withCAPA taken to address issues identified · 监测数据完整性问题，采取CAPA解决所识别出的问题 · Mechanisms for staff to report concerns tomanagement · 员工向管理层报告其担忧的机制 1.2 Objectives and Scope 目的与范围 Thisdocument is based on general Data Integrity requirements and gathers practicalexperiences from a number of companies operating in the sector that can be usedas guidance to others. It is not an all- inclusive list of requirements butproposes a comprehensive approach that companies can adopt to help carry outtheir data integrity risk assessments. 本文件是基于通用数据完整性要求，汇集了在该领域运营的大量公司的实用经验，可用于指导其它公司。它并非穷尽的需求清单，只是提出了一个全面的方法让公司可以用来帮助执行其数据完整性风险评估。 Theguide is essentially practical and therefore, after the presentation of theapproach and of the tools, the document includes some examples of executedassessments, categorisations and check lists that can be used by any companyaccording to their individual needs. Each company can choose the appropriate toolsand categorisations that apply to their own business processes and systems. 本指南基本是实用性的，因此在展示了方法和工具后，文件中包括了一些执行、分类和检查清单的实例，任何公司均可根据其自己需求加以使用。每个公司均可选择其适当的工具和分类方法，应用于其自己的业务流程和系统。 Thisguidance applies to all GxP processes and GxP data used in the manufacture andanalysis of APIs for use in human and veterinary drugs. 本指南适用于所有人药和兽药API生产和检验所用的GXP流程和GXP数据。 |
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