Klein Corbett S
Merck Research Laboratories, West Point, Pennsylvania 19486, USA.
Qual Assur. 2003 Apr-Jun;10(2):91-106. doi: 10.1080/10529410390262736.
Laboratory Information Management Systems (LIMS) play a key role in the pharmaceutical industry. Thorough and accurate validation of such systems is critical and is a regulatory requirement. LIMS user acceptance testing is one aspect of this testing and enables the user to make a decision to accept or reject implementation of the system. This paper discusses key elements in facilitating the development and execution of a LIMS User Acceptance Test Plan (UATP).
实验室信息管理系统(LIMS)在制药行业中发挥着关键作用。对此类系统进行全面而准确的验证至关重要,且是一项法规要求。LIMS用户接受度测试是该测试的一个方面,它能让用户决定是否接受系统的实施。本文讨论了有助于制定和执行LIMS用户接受度测试计划(UATP)的关键要素。