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...
7-纠正措施与预防措施CAPA(英)
Forexample: CAPA14001 (CAPA=Corrective actions & Preventive actions, 14=2014, 001=the first report of the year. 5.3.1.2填写“提出人”和提出日期。 Fillin “sponsor”andsponsordate 5.3.1.3对纠正预防措施问题进行描述。尽可能详细地参考相关程序,规定和客户要求 等。附上所有有帮助的其他信息资料。 Descr...
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
CAPA Pharmaceutical Services Corporation 美国医药服务有限公司 Corrective and Preventive Action 纠正预防行动 PDF 文件使用 "pdfFactory Pro" 试用版本创建www.fineprint.cn
Action PDF文件使用"pdfFactoryPro"试用版本创建.fineprint.cn 2 •CORRECTIVEACTION–Puttingoutafireafterithas started. 纠正行动:着火后进行灭火 •PREVENTIVEACTION–Observingconditionsthatmay startafireandremovingthemfromthesystem. 预防行动:观察可能引起火的条件,并从系统中除去它们 ...
This is not a comprehensive guide on corrective action and preventive action (CAPA) for a specific industry like a medical device, pharma, etc., but a simplified overview of CAPA, with an example of various industries. Always follow the standards applicable to you and your company!
Verification of corrective and preventive actions:Implemented. Ok, we are now at the last step of the CAPA for the malfunctioning implantable pacemaker (verification of corrective/preventive actions). For example, you have found out that a break in the wire insulation has led to the EC failure....
Corrective and preventive action (CAPA) procedure in most organizations is merely used to log problems. These organizations do not implement a robust CAPA process, and as a result they are still struggling today wit...
The Corrective and Preventive Action Process, or CAPA, is a systematic toolused to collect and analyze information on potential problems and create appropriate corrective and preventive actions to prevent a recurrence. The main objectives of the CAPA process include the establishment of immediatecorrectiv...