MDR Article 83.4和CAPA直接有关. “If, in the course of the post-market surveillance, a need for preventive orcorrective action or both is identified, themanufacturershall implement the appropriate measures and inform the competentauthoritiesconcerned and, where applicable, the notified body. Where a...
corrective and preventive actions 校正和预防措施(CAPA)是质量管理中至关重要的一部分。它们是一种用于矫正和预防问题的系统性方法,旨在确保产品和服务的质量,同时降低成本和提高效率。本文将介绍CAPA的概念、作用和实施方法。 CAPA是一种质量管理工具,它的主要目的是排除产品或服务中存在的问题,并预防这些问题再次发生...
Maintaining compliance with regulatory requirements is crucial in the rapidly evolving medical device manufacturing field. The Corrective and Preventive Action (CAPA) process is a cornerstone among these requirements. CAPA is a systematic approach to identifying, addressing, and preventing the recurrence of...
待解决 悬赏分:1 - 离问题结束还有 14.Corrective And Preventive Action (CAPA)问题补充:匿名 2013-05-23 12:21:38 14.Corrective和预防措施( CAPA ) 匿名 2013-05-23 12:23:18 14.纠正和预防措施(负荷) 匿名 2013-05-23 12:24:58 14.Corrective和预防措施 (CAPA) 匿名 2013-05-23 12:...
performanceandproductquality工艺性能和产品质量管理审核PDF文件使用"pdfFactoryPro"试用版本创建.fineprint.cn•Section3.2.2CorrectiveActionandPreventiveAction(CAPA)System第3.2.2章纠正行动和预防行动(CAPA)系统ØThepharmaceuticalcompanyshouldhaveasystemforimplementingcorrectiveactionsandpreventiveactionsresultingfromthe...
CAPA 是纠正措施和预防措施 (CAPA) 的缩写。MDR 的第2条对 CAPA 的定义进行了阐述。“上市后监督”指的是制造商与其他经济运营商合作，系统地收集和审查他们投放市场的设备所获得的经验，以便主动识别任何需要立即采取必要的纠正或预防措施的情况。“纠正措施”是指为消除潜在或实际的不合格或其他不良...
MasterControl's CAPA software is a robust, easy-to-use system designed to effectively manage CAPA processes and integrate with other quality processes critical to regulatory compliance, such as change control, audit and customer complaints.
如果一个伙伴在较少时间能投入由于个人情况,什么发生?[translate] asquaready squaready[translate] aIs there a corrective and preventive action (CAPA) procedure in use? If yes, summarize the procedure. 有没有一个矫正和预防措施 (CAPA) 做法在使用中? 如果是,总结做法。[translate]...
CAPA 纠正预防行动Corrective and Preventive Action精选.pdf,Pharmaceutical Services Corporation 美国医 服务有限公司 Corrective and Preventive Action 纠正预防行动 PDF 文件使用 pdfFactory Pro 试用版本创建 Definition 定义 CORRECTIVE ACTION Putting out a fire
Preventive action – I notice that the sharp corners of a table could cut someone (even though no one has been injured), so I take action to round the corners and change the future table design to have rounded corners. This is an example that uses a product problem, where CAPA in the...