本技术报告由全球制药行业和监管机构的主题专家编制，提供了建立健全的数据完整性管理系统所需的框架和工具，以确保实验室内纸质、混合和计算机化系统的数据完整性。它旨在概述监管要求和期望，以及最佳行业实践，以确保数据完整性，突出实验室数据管理实践中的常见差距，并推荐补救方法。

This Technical Report, developed by subject matter experts from the global pharmaceutical industry and regulatory agencies, provides the framework and tools necessary to establish a robust data integrity management system to ensure data integrity for paper, hybrid, and computerized systems within the laboratory. It is intended to outline regulatory requirements and expectations, along with best industry practices, to ensure data integrity, to highlight common gaps in laboratory data management practices, and to recommend methods of remediation.