Proper experimental record-keeping is an important cornerstone in research and development for the purpose of auditing. The gold standard of record-keeping is based on the judicious use of physical, permanent notebooks. However, advances in technology had resulted in large amounts of electronic records making it virtually impossible to maintain a full set of records in physical notebooks. Electronic laboratory notebook systems aim to meet the stringency for keeping records electronically. This manuscript describes CyNote which is an electronic laboratory notebook system that is compliant with 21 CFP Part 11 controls on electronic records, requirements set by USA Food and Drug Administration for electronic records. CyNote is implemented on web2py framework and is adhering to the architectural paradigm of model-view-controller (MVC), allowing for extension modules to be built for CyNote. CyNote is available at http://cynote.sf.net.
翻译:规范的实验记录是研发审计的重要基石。传统的黄金标准依赖纸质永久笔记本的审慎使用。然而,技术进步导致大量电子记录产生,使得在纸质笔记本中保存完整记录几乎不可能实现。电子实验室笔记本系统旨在满足电子记录保存的严格性要求。本文介绍了CyNote——一个符合美国食品药品监督管理局(FDA)电子记录规定(21 CFR Part 11)的电子实验室笔记本系统。CyNote基于web2py框架实现,遵循模型-视图-控制器(MVC)架构范式,支持扩展模块的构建。CyNote可通过http://cynote.sf.net获取。