Computer Software Assurance for Production and Quality System Software）。
美国FDA 指导原则 用户设备中工业血液建立计算机系统验证指南 英文原版.pdf,Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility Additional copies of this guidance are available from the Office of Communication, Outrea
The U.S. Food and Drug Administration (FDA) released the draft guidance “Computer Software Assurance(CSA) for Production and Quality System Software” in September 2022. The draft guidance provides an objective basis for subjective opinion, causing differing views o...
FDAstafforOfficeresponsibleforthisguidanceaslistedonthetitlepage. I.Introduction Off-the-shelf(OTS)Softwareiscommonlybeingconsideredforincorporationintomedical devicesastheuseofgeneral-purposecomputerhardwarebecomesmoreprevalent.Theuseof OTSSoftwareinamedicaldeviceallowsthemanufacturertoconcentrateontheapplication ...
美国FDA 指导原则 针对制造方法或工艺更改的30天通知、135天售前批准(PMA)补充和75天人道主义设备豁免(HDE)补充 英文原版.pdf,Contains Nonbinding Recommendations 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75- Day Humanitarian Device Exempt
(6Incomputerscience,validationreferstoensuringthatsoftwaremeetsitsspecifications.However,thismaynotmeetthedefinitionofprocessvalidationasfoundinguidanceforindustryProcessValidation:GeneralPrinciplesandPractices:“Thecollectionandevaluationofdata…whichestablishesscientificevidencethataprocessiscapableofconsistentlydeliveringquality...
In mid-2017 the FDA announced its digital health innovation action plan2 and began implementing plan commitments by hiring digital health staff, launching its digital health software precertification pilot program3 (Pre-Cert pilot program), and releasing three new guidance documents—two of which di...
this guidance also does not specifically discuss the validation of automated process control systems (i.e.,computer hardware and software interfaces), which are 32、 commonly integrated into modern drugmanufacturing equipment. this guidance is relevant, however, to the validation of processes that ...
1. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records. (21 CFR 211.68(b). 你公司未对计算机和相关系统进行适当控制,确保仅有经过授权的人员方可修改主生产...
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