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Posted 13 March 2018 | By Zachary Brennan 2018年3月13日由扎卡里.布莱南发布
Safeguarding data to ensure patient safety and the quality of medical products is at the forefront of new guidance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 保护数据安全以确保患者安全和医疗产品质量是英国药品和保健品监管机构（MHRA）的最新指导原则的前沿。
Data integrity issues have been cited frequently in US FDA Form 483s and warning letters for pharmaceutical and active ingredient manufacturers, as well as in statements of noncompliance with GMP from MHRA. 数据完整性问题在FDA的483、药品和API生产企业的警告信中，以及在MHRA的不符合GMP的声明中经常被提及。
Examples of such issues include attempts to dispose of or re-enter certain data on computer systems. 此类问题的例子包括试图处理或重新输入计算机系统的某些数据。
“The risks to data are determined by the potential to be deleted, amended or excluded without authorisation and the opportunity for detection of those activities and events,” MHRA’s guidance says. “The risks to data may be increased by complex, inconsistent processes with open-ended and subjective outcomes, compared to simple tasks that are undertaken consistently, are well defined and have a clear objective.” MHRA的指导说：“数据的风险是由在没有授权的情况下被删除、修改或被排除的可能性以及发现这些活动和事件的机会所决定的。” “数据的风险可能是由复杂、不一致的过程带来的，这些过程具有开放性和主观的结果，而与持续进行的简单任务相比，有清晰的定义和明确的目标。”
The guidance notes that both paper-based and electronic data can be used but data generated manually on paper “may require independent verification if deemed necessary from the data integrity risk assessment or by another requirement,” whereas the “inherent risks to data integrity relating to equipment and computerised systems may differ depending upon the degree to which the system generating or using the data can be configured, and the potential for manipulation of data during transfer between computerised systems during the data lifecycle.” 该指南指出，纸质和电子数据都可以使用，但在纸上手写的数据“可能需要独立的验证，如果从数据完整性风险评估或其他需求中被认为是必要的”。 然而，“与设备和计算机系统相关的数据完整性的内在风险可能不同，这取决于系统生成或使用数据的程度，以及在传输过程中对数据进行操纵的可能性。”
The guidance also defines certain terms and its interpretations at length, including what “raw” or source data means, what metadata is, what audit trails are, comparisons between “original record” and “true copy,” and definitions of data governance, data lifecycle and data transfers or migrations. 该指南还详细定义了某些术语及其解释，包括“原始”或源数据的含义、元数据是什么、审计跟踪是什么、“原始记录”和“真拷贝”之间的比较。以及数据治理、数据生命周期和数据传输或迁移的定义。
In terms of validating computerized systems, the guidance notes they “should be validated for their intended purpose which requires an understanding of the computerised system’s function within a process. For this reason, the acceptance of vendor-supplied validation data in isolation of system configuration and users intended use is not acceptable. In isolation from the intended process or end-user IT infrastructure, vendor testing is likely to be limited to functional verification only and may not fulfil the requirements for performance qualification.” 在验证计算机系统方面，该指南指出，他们“应该为其预期目的进行验证，这需要在一个过程中理解计算机系统的功能。” 由于这个原因，在系统配置和用户预期使用的隔离中接受供应商提供的验证数据是不可接受的。与预期的流程或最终用户IT基础设施隔离，供应商测试可能仅限于功能验证，可能无法满足性能要求。”
MHRA also notes that this guidance should be read in conjunction with the applicable regulations and the general guidance specific to each GXP. MHRA还指出，这个指导应该与适用的规则和特定于每个GXP的一般指导一起阅读。
“Where GXP-specific references are made within this document (e.g. ICH Q9), consideration of the principles of these documents may provide guidance and further information,” MHRA says. “在这个文档中（例如，ICHQ9）中有特定于GXP-特异性的引用，考虑这些文档的原则可以提供指导和进一步的信息，”MHRA说。
In August 2016, the European Medicines Agency and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) also released draft guidance and a question and answer document to help ensure that data integrity is maintained during the process of testing, manufacturing, packaging, distributing and monitoring medicines. 2016年8月，欧洲药品局和药品检验合作计划（pic/s）也发布了草案指南和一个问答文件，以确保在测试过程中保持数据完整性，生产、包装、分发和监测药品。
Medicines & Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions. 药品与保健产品监管机构（MHRA）GXP的数据完整性指导和定义。
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