WHO数据完整性指南2019.10(中英对照)

QAS/19.819GUIDELINE ON DATA INTEGRITY数据完整性指南(October 2019)2019 年10 月1. INTRODUCTION AND BACKGROUND前言与背景1.1. Data governance and data integrity (DI) are important elements in ensuring the reliability of data and information obtained in production and control of pharmaceutical products. The data and information should be complete as well as being attributable, legible, contemporaneous, original and accurate, commonly referred to as meeting “ALCOA” principles.数据管理与数据完整性（DI）是确保药品生产和检测期间所获得的数据和信息可靠性的重要要素。

这些数据和信息应完整，同时具有可追溯性、清晰、同步、原始和准确，一般称为符合“ALCOA”原则。

1.2. In recent years, the number of observations made regarding the integrity of data, documentation and record management practices during inspections of good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP) has been increasing. Possible causes for this may include (i) too much reliance on human practices; (ii) the use of computerized systems that are not appropriately managed and validated; and (iii) failure to adequately review and manageoriginal data and records.近年，在 GMP、GCP 和 GLP 检查中，数据完整性、文件记录管理规范性方面的缺陷数量大大上升。

可能的原因大致包括（1）太过依赖人员操作，（2）使用了未进行恰当管理和验证的计算机化系统，以及（3）未充分审核和管理原始数据与记录。

1.3. Quality risk management (QRM), control strategies and sound scientific principles are required to mitigate such risks. Examples of controls may include, but are not limited to:降低此类风险需要有质量风险管理（QRM）、控制策略和科学合理原则。

控制实例可包括但不仅限于：•the establishment and implementation of a DI policy;•制订和实施 DI 方针；•the establishment and implementation of procedures that willfacilitate compliance with DI requirements and expectations;•制订和实施有利于符合 DI 要求和预期的程序；•adoption of a quality culture within the company that encourages personnel to be transparent about failures which includes a reporting mechanism;•在公司内推行质量文化，鼓励员工坦白失败，包括报告机制；•application of QRM with identification of all areas of risk to DI through data integrity risk assessment (DIRA) and implementation of appropriate controls to eliminate or reduce risks to an acceptable level throughout the life cycle of the data;•应用 QRM，通过数据完整性风险评估（DIRA）识别所有领域的 DI 风险，在数据整个生命周期中实施适当控制消除或降低风险至可接受水平；•ensuring sufficient resources to monitor compliance with DI policies and procedures and processes, and facilitate continuous improvement;•确保有足够的资源监测 DI 方针以及程序和流程遵守情况，促进持续改进；•provision of necessary training for personnel in, for example, good practices (GXP), computerized systems and DI;•为员工提供必要的培训，如，优良规范（GXP）、计算机化系统和 DI；•implementation and validation of computerized systems appropriate for their intended use;•根据其既定用途实施和验证计算机化系统；•definition and management of appropriate roles and responsibilities for quality agreements and contracts entered into by contract givers and contract acceptors.•作为合同委托方或接受方签署的质量协议和合同中适当角色与职责的定义和管理。

2. SCOPE范围2.1. This guideline provides information, guidance and recommendations to facilitate compliance with DI, GXP in documentation and record keeping requirements.本指南提供促进 DI、GXP 在文件和记录保存要求方面的合规性信息、指南和建议。

2.2. The scope of this guideline is designated as ‘GXP’. It does not, however, cover medical devices.本指南的范围规定为“GXP”。

但并不覆盖医疗器械。

2.3. Where possible, this guideline has been harmonised with other published documents. The guideline should be read with other WHO GXP guidelines and publications.如可能，本指南已与其它已发布文件保持统一。

本指南应与其它 WHO GXP 指南和出版物联合解读。

2.4. In line with the current approach in GMP, it recommends a risk-based approach over the life cycle of data. DIRA should be carried out in order to identify and assess areas of risk.根据 GMP 中的当前方法，建议对数据生命周期采取基于风险的方法。

应执行 DIRA 以识别和评估风险领域。

2.5. The principles of this guideline apply to contract givers and contract acceptors. Contract givers are ultimately responsible for the integrity of data provided to them by contract acceptors. Contract givers should therefore ensure that contract acceptors comply with the principles contained in this guideline.本指南的原则适用于合同委托方和合同接受方。

合同委托方最终对合同接受方提交给他们的数据的完整性负责。

委托方因此应确保合同接受方符合本指南所含原则。

2.6. Efficient risk-based controls and review of data and documents should be identified and implemented. The effectiveness of thecontrols should be verified.应识别并实施对数据和记录的基于风险的有效控制与审核。

控制的有效性应进行验证。

3. GLOSSARY 术语(Note: This section will be updated)（注：本部分将进行更新）The definitions given below apply to the terms used in these guidelines. They may have different meanings in other contexts. 以下定义适用于本指南所述术语。

可能与其它语境含义有所不同。

ALCOA.A commonly used acronym for “attributable, legible, contemporaneous, original andaccurate”. 常用术语，代表“可追溯性、清晰、同步、原始和准确”。