111 ANNEX11 COMPUTERISEDSYSTEMS Principle Theintroductionofcomputerisedsystemsintosystemsofmanufacturing,including storage,distributionandqualitycontroldoesnotaltertheneedtoobservetherelevant principlesgivenelsewhereintheGuide.Whereacomputerisedsystemreplacesamanual operation,thereshouldbenoresultantdecreaseinproductqualityor...
Learn about the updates to EU Annex 11 and how MasterControl can help achieve compliance with EU Annex 11 computerised software systems.
21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while...
The article focuses on the integrity of electronic records (erecs) in relation to the proposed guidelines of the European Union (EU) Annex 11 under the good manufacturing processes (GMPs). Topics discussed...
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
The scope of the AI Act is very wide, covering systems developed through an array of approaches that are listed in Annex I of the AI Act. These include machine learning approaches that also incorporate deep learning; logic and knowledge-based approaches; as well as statistical approaches, ...
我们从概念文件已经明显感到,随着技术和法规的发展,当前的Annex 11在一定程度上已经需要进行调整,对于新版的草版我们拭目以待,它必将更好地指导我们科学合理地应用新技术。但是,监管要求的进一步细化,势必将增加企业管理的多样性,因此我们需要提前准备,在尽早提高公司计算机化系统合规性管理的同时,避免后期累积过多的合...
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...
well,” said Martin Browning, president and co-founder of EduQuest in the white paper “Annex 11: The EU’s New Expectations for Regulated Computerized Systems.”(1)“However, the two documents approach this goal differently. Annex 11 is ‘how to’ in tone while Part 11 is ...