Danley Merry
Celerion, 621 Rose Street, Lincoln, NE 68502, USA.
Bioanalysis. 2011 Jul;3(13):1479-85. doi: 10.4155/bio.11.134.
The purpose of this article is to articulate the fundamental issues of archiving electronic GLP data in a CRO environment. CROs struggle to address the absolute requirement of archiving GLP studies electronically. The difficulty of adhering to this is partly due to the wide variety of systems and types of electronic data. Often the end solution to this complicated issue is printing the data at the end of the study and in turn archiving the paper data, foregoing or ignoring the fact that scientific decisions were made while reviewing electronic data. Paper data and electronic data can be different. For example, chromatographic resolution or being able to focus in on detailed integration of chromatograms can significantly change the perspective of the data. While the core goal of archiving according to GLP principles are met, the reality is much different. Businesses purchasing CRO capabilities and regulatory agencies have been quite clear that when it comes to auditing the data that the electronic record is the preferred and often required source of the information for auditing and review purposes. The fact is that paper data do not always provide the flexibility, sensitivity and complete data context that an electronic record can provide. The ability to adhere to compliance standards due to the electronic data cannot be undervalued and by printing the data after all the acquisition, decisions, scientific judgments and review, do a complete disservice to the multidimensional (such as colors for deactivated or changed data, audit trails, 'zooming-in functionality', direct data links and snapshots) data in an electronic system.
本文的目的是阐明在合同研究组织（CRO）环境中存档电子GLP数据的基本问题。CRO在努力满足电子存档GLP研究的绝对要求方面面临困难。难以遵守这一要求的部分原因是电子数据的系统和类型多种多样。通常，这个复杂问题的最终解决方案是在研究结束时打印数据，进而存档纸质数据，却忽略了在审查电子数据时已经做出科学决策这一事实。纸质数据和电子数据可能会有所不同。例如，色谱分辨率或能够专注于色谱图的详细积分可能会显著改变数据的视角。虽然根据GLP原则进行存档的核心目标得以实现，但实际情况却大不相同。购买CRO服务的企业和监管机构已经非常明确，在审核数据时，电子记录是审计和审查首选且通常必需的信息来源。事实上，纸质数据并不总是能提供电子记录所能提供的灵活性、灵敏度和完整的数据背景。不能低估因电子数据而遵守合规标准的能力，而在所有数据采集、决策、科学判断和审查之后打印数据，对电子系统中的多维数据（如停用或更改数据的颜色、审计追踪、“放大功能”、直接数据链接和快照）完全是一种损害。
