I took your "Complying with Computer and Software Validation Requirements" through PTi in February (San Diego). This is just an unsolicited positive review of that course -- I've since had a couple of other training courses (completely different topics, completely different companies), and I ju...
Get Software Validation Training Join a software validation class, attend a free special topic webinar, or bring training to your site. Our team has developed educational courses and webinars to help you apply the FDA, ICH, and Eudralex risk-based validation concepts to your projects. Our co...
2 设计空间探索 Design space exploration 3 仿真器验证 Simulator validation ■ 2 性能评估方法的未来工作 Future work in performance evaluation methods 1 软件方面的挑战 Challenges related to software 2 硬件方面的挑战 Challenges related to hardware 3 结语 Final comment 序言 本书目的 本书的目的在于对当下...
Validation strategy The validation strategy, and thus the extent of the validation activities, depends ultimately on the maturity and complexity of the computer software component(s) implied in ISPE GAMP5 and partly FDA 21 CFR 211.68(b) (6, 1). Computer software, as part of the computer ...
Validation of computer-based training in ureterorenos- copy. BJU Int. 2005 Jun;95(9):1276-1279.Knoll T,Trojan L,Haecker A,Alken P,Michel MS.Validation of computer-based training in ureterorenoscopy. BJU International . 2005Knoll T,Trojan L,Haecker A,Alken P,Michel MS.Validation of ...
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.
建立系统定义 Validation plan 验证计划 Completion of IQ , OQ, PQ 完成IQ , OQ, PQ SOPs—operational 关于SOP – 操作的 SOPs—admin/maint 关于SOP – 管理/维修 Current training procedures records 当前培训程序记录 4.3 Attribute #1: Configurability of the Application Program or Software—Configurable ...
CSA started surfacing around 2019 through various channels such as training, webinars, and articles. It quickly became evident that the FDA was embracing a leaner approach to Computer System Validation (CSV), and we immediately understood its potential benefits. Streamline Validation & Save Money ...
The awareness section of the training is used to train the learner to become aware of the assumptions they are making Validation Section The second phase of the training shows the learner that it is important not only to be aware that they are making assumptions, but that they must validate ...
ValidationPhases4QModelDesignQualificationInstallationQualificationOperationalQualificationPerformanceQualification Userrequirementspecifications Functionalspecifications Operationalspecifications Vendorqualification Checkarrivalaspurchased Checkproperinstallationofhardwareandsoftware Testofoperationalfunctions Performancetesting Testof...