資格?/?計算機系統(tǒng)驗證

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)管理的可靠性進行驗證。為此客戶需要可通過驗證的軟件和設備，結合了兼容ROTRONIC HW4的設備和軟件，ROTRONIC可提供整套驗證解決方案。設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)絡應用

標準版的所有功能

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