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更新時間:2021-08-12 16:10:17瀏覽次數(shù):460次
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數(shù)據(jù)完整和安全在今時益發(fā)重要,制藥、食品、醫(yī)療技術(shù)等產(chǎn)業(yè)必須對系統(tǒng)數(shù)據(jù)測量和數(shù)據(jù)管理的可靠性進(jìn)行驗證。為此客戶需要可通過驗證的軟件和設(shè)備,結(jié)合了兼容ROTRONIC HW4的設(shè)備和軟件,ROTRONIC可提供整套驗證解決方案。設(shè)備和軟件符合電子數(shù)據(jù)記錄和電子簽名的要求FDA 21 CFR Part 11 (美國食品和藥物管理局(FDA)) 和 GxP.
制藥和食品行業(yè)的網(wǎng)絡(luò)應(yīng)用
標(biāo)準(zhǔn)版的所有功能
滿足電子數(shù)據(jù)記錄和簽名的要求(21CFR第11部分,附件11)
分組設(shè)備,圖形疊加,報表打印
支持的操作系統(tǒng)
Microsoft Windows XP Service Pack 2,Vista,Windows 7,Windows 8,Windows 10
主要特點(diǎn)Viewing of measured values/Monitoring
Display of measured values on the monitor for one & more instruments
Monitor display of measured values consolidated into groups
ROTRONIC networkable
Archiving of data
Automatic saving of the measured data (monitoring)
Simultaneous management of the log settings for instruments in a group
Display of the measured values
Numeric and graphic display
Graphic comparisons and overlay functions
Customer-specifi c room layout
Analysis and calculation tool
Psychrometric calculations
Statistics
Printing/Reports
Automatic generation of adjustment, calibration and confi guration reports
Printout as table or graph
Users and passwords
Password protection
User names and rights free defi nable
Alarms
Visual display of active alarms
Alarm via , SMS, relay, report printout
Flexible programming of alarm evaluation, pre- and main alarm, own alarm evaluation possible for every instrument
Electronic record, electronic signature, audit trail
Logging of all HW4 user events & automatic generation of reports
Verifi ability of manipulations guaranteed at all times
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