这个就是在确认工作中要考虑软件使用的风险。 关于软件确认的框架要求,如果大家想要了解具体该怎么做,在指南文件里面有提到一个标准(ISO/TR 80002-2 Medical device software-Part 2: Validation ofsoftware for medical device quality systems),大家可以去参考,也可以去查看相关文献。 收起全文 赞同 4 0评论 分...
針對醫療器材專有名詞作更明確的定義整合全球法規要求整合風險管理與以及在整個品質管理系統中以風險為基礎進行決策針對醫療器材檔案 (medical device file) 提出更明確的架構針對查證、確認與設計管制提出更清楚的要求強化供應鏈的管制加強對回饋機制的關注針對各種軟體應用,提出更明確的軟體確認 (software validation) ...
Procedures for risk based software validation;? Documented procedure for product identification/status during production; this may be Unique Device Identi 18、fication (uDl),? Validation of sterile barrier systems; ? Suitability of packaging systems;? Recording of measuring equipment adjustments.Evidence ...
Validation-confirmation,throughtheprovisionofobjectiveevidence,thattherequirementsfora specificintendeduseorapplicationhavebeenfulfilled. ForQSR820.z-ValidationincludesProcessvalidation…Processvalidationmeansestablishingby objectiveevidencethataprocessconsistentlyproducesaresultorproductmeetingits ...
? Validation of software. ALL Clause 4.2-Documentation requirements Updates required: ? Clauses 6, 7 and 8; ? Medical device file; ? Controls related to document and record amendment, security and integrity Clause 5 -Management Responsibility ? Increased focus on regulatory requirements; ? Documente...
7.4 If the audited Design project contains software, is there evidence that the software is validated (such as specification, code reviews, module testing, validation, release, etc.)? 若被审核的设计项目包含软件,是否有证据表明软件被确认过(例如规范、代码评审、模块测试、确认、发放,等)? 7.5 Is ...
14、h and activities associated with software validation and revalidationshall be proportionate to the risk associated with the use of the software.Records of such activities shall bemaintained (see 4.2.5).与软件验证和再验证相关的专门方法和措施应当使用该软件的风险相适应。这类措施的记录应当被保留(见...
4.1.6 The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application....
4.1.6 The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application. 组织应当建议文件...
Thespecific approach and activitiesassociated with software validationand revalidation shall be proportionate to therisk associated withthe use of the software, including the effect on theability of theproduct to conform to specifications. Records of the resultsandconclusion of validation and necessary acti...