美国FDA 于 9 月 13 日发布了与医疗器械生产相关的《生产和质量系统软件的计算机软件保证》(Computer Software Assurance for Production and Quality System Software)指南草案。【点击识林小程序,阅读指南】 FDA 表示,该指南草案是为作为医疗器械生产或质量体系的一部分的计算机和自动数据处理系统提供计算机软件保证。指...
Computer Software Assurance for Production and Quality System Software）。
The U.S. Food and Drug Administration (FDA) released the draft guidance “Computer Software Assurance(CSA) for Production and Quality System Software” in September 2022. The draft guidance provides an objective basis for subjective opinion, causing differing views of...
Computer Software Assurance (CSA) is a Case for Quality initiative that arose when computer systems validation was identified as a barrier to adopting technology for modernization and innovation. The FDA recognizes the value of using advanced technologies to enable the industry to make medicines of ...
Computer Software Assurance for Production and Quality System Software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers Draft Guidance Topics 3D Printing Medical Devices at the Point of Care Retrospective Review List of Guidances for 1984, 1994, 2004, and 2014 ...
*FDA defines “least burdensome’’ as the minimum amount of information necessary to adequately address a relevant regulatory question or issue most efficiently at the right time.4Moreover, FDA has further clarified the use of least burden...
Computer Software Assurance for Production and Quality System Software Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Publi...
FDA也认识到这个问题,因此一直在寻找新的方法,进行各种各样的尝试,经过长达十年的摸索,宣布将在今年发布新的指南“ComputerSoftware Assurance for Manufacturing, Operations, and Quality System Software”。估计未来几个月大家就会看到正式版本的发布。下面一起看下FDA的探索之路。 来看下CSV到CSA后的对比图: 从CSV...
The American National Standards Institute (ANSI) defines systems as people, machines, and methods organized to accomplish a set of specific functions.7 Computer or related systems can refer to computer hardware, software, peripheral devices, networks, cloud infrastructure, personnel, and associated docum...
In computer science, validation refers to ensuring that software meets its requirements. However, this may not meet the definition of process validation as found in guidance for industry Process Validation: General Principles and Practices: “The collection and evaluation of data … which establishes ...