These companies are required by the guideline to implement various controls in the processing of electronic data. What are 21 CFR part 11 requirements? There are various requirements necessary to be compliant with 21 CFR part 11. This includes the generation of accurate and complete copies of ...
According to FDA guideline 2016, to prove that the results of the “training set (candidate CDx)” sample used to establish the clinical decision point and analysis criteria are very similar to the clinical trial assay (CTA), a “bridging study” between the two tests can be conducted by ...
History and Expectations As applied by the FDA and Implemented by Industry 第三部分:验证历史与FDA和制药行业对验证的期望 History and expectations Learn for the experiences of the USA manufacturers and industry organizations Current applications Past citations Industry guidelines ICH Q7A ISPE PDA Etc. 历...
Joseph Famulare - FDA从政府监管角度看cGMP和21 CFR Part11 的更新 英文
验室质量 控制 检查指南 (1993 年 5 月) (The Guide To Inspections of Microbiological Pharmaceutical Quality Control Laboratories (May, 1993) ) 也提供了 相关 的指导信 息。 Chank 解读 的确如此,该指南对于厂家做系统设计和设施设备确认的指导意义并不大。对于厂家制定相关的运行操作规程和系统维护规程的...