Jones R D, Weyrauch T A, Bailey S R, Halder C A
Toxicology Department, Bayer Corporation, Stilwell, KS 66085-9104, USA.
Qual Assur. 1997 Jan-Mar;5(1):1-17.
Since there was a scientific need to conduct electrophysiology measurements to detect possible ocular (electroretinography, ERG), central neurotoxic (quantitative electroencephalography, qEEG), and cardiac (electrocardiography, ECG) effects in animals used in certain regulatory studies, the acquisition of suitable automated PC software systems were required. This article describes the process by which these systems were validated to ensure that they met the scientific requirements, while also addressing the principles of Good Automated Laboratory Practices (GALP). After a thorough search of existing commercial packages, a plan was developed specific for each PC-based collection system selected for evaluation. The common elements of each plan included consideration of both scientific and GALP elements, such as necessary biological response variables, raw data acquisition and identification, acceptance criteria, security, protection, storage media, data integrity, audit requirements and standard operating procedures. The authors' approach to validation for each electrophysiology system was to determine scientific needs for accuracy, precision, and detection limit of biological effects concurrent with GALP requirements. The selected software systems were employed in separate scientific GLP studies conducted in dogs, rats, and mini-pigs to demonstrate the ability to detect cholinesterase effects due to multiple infusions of physostigmine, based on parallel measurement of cholinesterase biomarkers. Since the systems were designed for human usage, certain adaptations were necessary. A critical assumption to be tested was the ability of the system's algorithms to adequately capture and assimilate the data in an accurate fashion. Concomitantly, the related GALP needs, such as data integrity, security, CD-ROM archive, and personnel training requirements were evaluated, implemented, and defined to accommodate the application and process needs. The biological approach to validation of these PC-based electrophysiology systems met the necessary scientific acceptance criteria as well as compliance requirements in order to be used in regulatory studies.
由于在某些监管研究中使用的动物身上进行电生理测量以检测可能的眼部（视网膜电图，ERG）、中枢神经毒性（定量脑电图，qEEG）和心脏（心电图，ECG）效应存在科学需求，因此需要购置合适的自动化个人计算机软件系统。本文描述了对这些系统进行验证的过程，以确保它们符合科学要求，同时还阐述了良好自动化实验室规范（GALP）的原则。在对现有的商业软件包进行全面搜索之后，针对每个选定用于评估的基于个人计算机的采集系统制定了具体计划。每个计划的共同要素包括对科学和GALP要素的考虑，例如必要的生物反应变量、原始数据采集与识别、验收标准、安全性、保护措施、存储介质、数据完整性、审计要求和标准操作程序。作者对每个电生理系统的验证方法是，在确定生物效应的准确性、精密度和检测限的科学需求的同时，兼顾GALP要求。所选软件系统用于在狗、大鼠和小型猪身上分别进行的科学GLP研究，以基于对胆碱酯酶生物标志物的平行测量来证明检测因多次注射毒扁豆碱而产生的胆碱酯酶效应的能力。由于这些系统是为人类使用而设计的，因此需要进行某些调整。一个需要测试的关键假设是系统算法以准确方式充分捕获和同化数据的能力。与此同时，对相关的GALP需求，如数据完整性、安全性、光盘存档和人员培训要求进行了评估、实施和定义，以适应应用和流程需求。对这些基于个人计算机的电生理系统进行验证的生物学方法符合必要的科学验收标准以及合规要求，以便用于监管研究。
