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HW4-P

资格 / 计算机系统验证
数据完整和安全在今时益发重要,制药、食品、医疗技术等产业必须对系统数据测量和数据管理的可靠性进行验证。为此客户需要可通过验证的软件和设备,结合了兼容ROTRONIC HW4的设备和软件,ROTRONIC可提供整套验证解决方案。设备和软件符合电子数据记录和电子签名的要求FDA 21 CFR Part 11 (美国食品和药物管理局(FDA)) 和 GxP.

制药和食品行业的网络应用
标准版的所有功能
满足电子数据记录和签名的要求(21CFR第11部分,附件11)
分组设备,图形叠加,报表打印

支持的操作系统
Microsoft Windows XP Service Pack 2,Vista,Windows 7,Windows 8,Windows 10

主要特点

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 email, 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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