EMA GMP Q&A on Annex 11 and Q&A EMA GCP Guideline on computerised systems and electronic data in clinical trials (draft), EMA/226170/2021EMA GCP Q&A no. 8, 9, and Notice to sponsors on validation and qualification of computerised systems used in clinical trialsEMA GVP Q&A on Level of val...
eugmpannex11计算机控制系统+eugmpannex8原辅料 和包装材料的取样 预览说明:预览图片所展示的格式为文档的源格式展示,源文件没有水印,内 容可编辑和复制 附件11 COMPUTERISEDSYSTEMS计算机控制系统 Principle原则 Theintroductionofcomputerisedsystemsintosystemsof ...
Validationaccording to paragraph 4 of annex 11 is required at least for spreadsheets thatcontain custom code (e.g. Visual Basic for applications). Formulas or othertypes of algorithm should be verified for correctness. 根据附录11第4段,对数据表格所需要进行的验证至少包括定制代码(例如visual Basic应用...
17-EUGMP 附录11 Annex 11 Computerised Systems
eugmpannex11计算机控制系统+eugmpannex8原辅料和包装材料的取样.pdf,附件 11 COMPUTERISED SYSTEMS 计算机控制系统 Principle 原则 The introduction of computerised systems into systems of manufacturing, including storage, distribution and quality control does n
EU-GMP-Part-II-Annexes-12 热度: EU-GMP-Part-II-Annexes-13.pdf 热度: Exhibition-of-Master-Wan-Ko-Yee's-Amazing-Achievement-in-the-Form-of-World-Class-Treasures 热度: 111 ANNEX11 COMPUTERISEDSYSTEMS Principle Theintroductionofcomputerisedsystemsintosystemsofmanufacturing,including ...
1.[New] The document should be updated to replace relevant parts of the Q&A on Annex 11 and the Q&A on Data Integrity on the EMA GMP website. [新增]该文件应更新,以取代EMA GMP网站上的附录11问答和数据完整性问答的相关部分。 2. [New] With regards to data integrity, Annex 11 will includ...
EU GMP 附录11:计算机化系统-英文 下载积分: 100 内容提示: Principle This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities. The application...
EU GMP guide annexes - Supplementary requirements: Annex 11 Computerised Systems 1. Appropriate controls for electronic documents such as templates should be implemented. Are there any specific requirements for templates of spreadsheets? (H+V February 2011)Templates of Spreadsheets helps to avoid ...
eu gmp annex 11 中文 WHO GMP Sterile 2010 Annex 4 TRS957_2010.doc,eu gmp annex 11 中文 WHO GMP Sterile 2010 Annex 4 TRS957_2010 导读:就爱阅读网友为您分享以下“WHO GMP Sterile 2010 Annex 4 TRS957_2010”的资讯,希望对您有所帮助,感谢您对92的支持! Table 2