MHRA数据完整性指南.docx

MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015
MHRA的GMP数据完整性定义和行业指南/2015年3月
Introduction: 背景f generally accepted scientific （纸质）和电子数据。生产商和分析化验室应明白将自动化的
/计算机化的系统转换为人工/纸质的系统并不能消除数据完整性控制的需求。这可能也会是违反法条2001/83/EC第23款的，该条款要求自动化的持有者要考虑科学技术进步，使得药品采用普遍被接受的科学方法进行生产和检查。Throughout this guidance, associated definitions are shown as 。Establishing data criticality and inherent integrity risk:建立数据关键性和内在完整性风险In addition to an overarching data governance system, which should include relevant policies and staff training in the importance of data integrity, consideration should be given to the organisational (. procedures) and technical (. computer system access) controls applied to different areas of the quality system. The degree of effort and resource applied to the organisational and technical control of data lifecycle elements should be commensurate with its criticality in terms of impact to product quality ，还要考虑将组织性（例如，程序）和技术性（例如，计算机系统进入权限）控制应用于质量体系的不同领域。应用于组织性和技术性控制数据生命周期要素的努力程度和资源配置情况应与其对产品质量属性的影响关键性相适应。Data may be generated by (i) a paper-based record of a manual observation, or (ii) in terms of equipment, a spectrum of simple machines through to complex highly configurable computerised systems. The inherent risks to data integrity may differ depending upon the degree to which data (or the system generating or using the data) can be configured, and therefore potentially manipulated (see figure 1).数据可以由以下方式产生（1）人工观察纸质记录（2）仪器，简单设备通过复杂的高级参数计算机化系统产生的图谱。数据完整性的内在风险根据数据可设置参数水平不同而不同，因此是可以捏造的（参见图1）。
With reference to figure 1 above, simple systems (such as pH meters and balances) may only require calibration, whereas complex systems require ‘validation for intended purpose’. Validation effort increases from left to right in the diagram above. However, it is common for companies to overlook systems of apparent lower complexity. Within these systems it may