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...
7. Before a system using a Before a system using a computer is brought into use, it should be thoroughly tested and 1 “eugmpannex11 计算机控制系统+eugmpannex8 原辅料和包装材料的取样”文档源于网络,本人编辑整理。本着保护作者知识产权的原则,仅供学习交流,请勿商用。如有侵犯作者权益,请作者留言戒...
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...
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
0/0 收藏人数: 0 评论次数: 0 文档热度: 文档分类: 经济/贸易/财会--财政/国家财政 文档标签: IIEU帮助pdfPDFEUGMP11GMPPartpart 111 ANNEX11 COMPUTERISEDSYSTEMS Principle Theintroductionofcomputerisedsystemsintosystemsofmanufacturing,including storage,distributionandqualitycontroldoesnotaltertheneedtoobservetherel...
17-EUGMP 附录11 Annex 11 Computerised Systems
EUGMP guide annexes: Supplementary requirements: Annex 11: Computerised systems EU GMP指南附录:补充要求:附录11:计算机化系统 1.Appropriate controls for electronic documents such as templates should beimplemented. Are there any specific requirements for templates of spreadsheets?H+V February 2011 对于电子...
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 not alter the need to observe the relevant principles given elsewhere in the Guide. Where a computerised system replaces ...
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 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 ...