CSV(computerized system validation)的概念作为我们执行计算机系统验证与合规的基石已经有很长一段时间了,而且也越来越被大家感觉到方法虽好,但是负担也很重,某种意义上跟不上目前制药行业日新月异的新技术的应用。在这种背景下,CSA(computerized system assurance)应运而生。 自从1997年,FDA发布了21 CFR Part 11及...
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 ...
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...
o Provisions for oversight from quality assurance (QA) managers, executives, and internal auditors with appropriate IT expertise (e.g., infrastructure; configuration; network requirements; segregation of duties including administrator rights). o 由具备适当IT专业知识(例如,基础设施;配置;网络要求;职责分离...
” See also ICH guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, which defines validation as providing assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria. For purposes of this ...
your document management system. When production employees reported an “error” in a record, your production manager printed a blank copy and had the employee transcribe the information on the new record and discarded the old record. There is no ass...
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...
” See also ICH guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, which defines validation as providing assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria. For purposes of this ...
David Nettleton is an FDA Compliance, 21 CFR Part 11, Computer System Validation, Software Implementation, Computer Software Assurance, and HIPAA Specialist for healthcare, pharmaceutical, and medical device applications.
Quality AssuranceAuditing Services We perform detailed assessments of your existing quality system, identify current and potential problems, recommend corrective and preventive actions, and work closely with your staff to implement these improvements to your quality system. We analyze FDA’s inspection hist...