Elvebak Larry E
Gubbs Inc., 265 Blue Spruce Circle, Alpharetta, GA 30005, USA.
Bioanalysis. 2011 Jul;3(13):1421-7. doi: 10.4155/bio.11.101.
The final product of analytical laboratories performing US FDA-regulated (or GLP) method validation and bioanalysis studies is the final report. Although there are commercial-off-the-shelf (COTS) software/instrument systems available to laboratory managers to automate and manage almost every aspect of the instrumental and sample-handling processes of GLP studies, there are few software systems available to fully manage the GLP final report preparation process. This lack of appropriate COTS tools results in the implementation of rather Byzantine and manual processes to cobble together all the information needed to generate a GLP final report. The manual nature of these processes results in the need for several iterative quality control and quality assurance events to ensure data accuracy and report formatting. The industry is in need of a COTS solution that gives laboratory managers and study directors the ability to manage as many portions as possible of the GLP final report writing process and the ability to generate a GLP final report with the click of a button. This article describes the COTS software features needed to give laboratory managers and study directors such a solution.
进行美国食品药品监督管理局（FDA）监管（或符合良好实验室规范，GLP）方法验证和生物分析研究的分析实验室的最终成果是最终报告。尽管实验室管理人员可以使用现成的商业（COTS）软件/仪器系统来自动化和管理GLP研究中仪器和样品处理过程的几乎每个方面，但用于全面管理GLP最终报告编制过程的软件系统却很少。缺乏合适的COTS工具导致实施相当复杂且手动的流程，以拼凑生成GLP最终报告所需的所有信息。这些流程的手动性质导致需要多次反复进行质量控制和质量保证活动，以确保数据准确性和报告格式。该行业需要一种COTS解决方案，使实验室管理人员和研究负责人能够管理GLP最终报告编写过程中尽可能多的部分，并能够通过点击按钮生成GLP最终报告。本文描述了为实验室管理人员和研究负责人提供此类解决方案所需的COTS软件功能。
