QAS/19.819

GUIDELINE 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 manage original 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 will facilitate 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。

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