第84号PDA技术报告（TR 84）:将数据完整性要求集成到制造和包装操作中，从制造操作的角度解决了数据完整性问题。它讨论了适用于纸质、电子和混合系统的制造操作中实施适当数据完整性控制的监管趋势、风险管理概念和建议。本技术报告中的案例研究提供了如何评估当前数据完整性风险和实施报告中提出的概念的示例。本技术报告描述了一种使用质量风险管理（QRM）的方法，用于根据数据的关键性和脆弱性，为每个制造操作建立和评估数据完整性控制的适当性。 TR 84由全球行业和监管机构的主题专家开发，总结了制造业数据完整性风险，并确定了可用于开发和维持稳健文档以及数据完整性管理程序、系统、流程和控制的最佳实践。采用这些做法将帮助用户遵守适用的法律、法规和医药产品指令，如活性药物成分（API）、固体口服剂型、无菌注射剂、生物制品和疫苗。

PDA Technical Report No. 84 (TR 84): Integrating Data Integrity Requirements into Manufacturing and Packaging Operations addresses data integrity from the perspective of manufacturing operations. It discusses regulatory trends, risk management concepts, and recommendations for implementing appropriate data integrity controls in manufacturing operations applicable to paper-based, electronic-based, and hybrid systems. The case studies included in this technical report provide examples of how to assess current data integrity risks and implement the concepts presented in the report.This technical report describes an approach using quality risk management (QRM) for establishing and assessing the appropriateness of data integrity controls for each manufacturing operation based on the criticality and vulnerability of the data for its intended use.Developed by subject matter experts from global industry and regulatory agencies, TR 84 summarizes manufacturing data integrity risks and identifies best practices that can be used to develop and sustain robust documentation, as well as data integrity management procedures, systems, processes, and controls. Employing these practices will help users achieve compliance with applicable laws, regulations, and directives for pharmaceutical products such as active pharmaceutical ingredients (APIs), solid oral dosage forms, sterile injectables, biologics, and vaccines.