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Jakarta Office :

021-45850618


Surabaya Office :

031-8421264

 
Rotronic HW4-P Software

Qualification / Computerized system validation
Data integrity and security are of essential importance today. Companies in the pharmaceutical, food, and medical technology industries must prove that their data is measured and managed reliably. For this they require software and devices that can be validated. Combining ROTRONIC HW4-compatible instruments and software, ROTRONIC provides solutions in which validation plays a central role. The instruments and software are validated and compatible with FDA 21 CFR Part 11 (directive of the US Food and Drug Administration, FDA) and GxP.

Network applications in the pharmaceutical and food industries
All function of the standard edition
Fulfils the requirements for electronic data records and signatures (21CFR Part 11, Annex 11)
Grouping of devices, graph overlays, printing of reports

Supported operating systems
Microsoft Windows XP Service Pack 2, Vista, Windows 7, Windows 8, Windows 10

Features

  • 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-specific room layout
  • Analysis and calculation tool
    • Psychrometric calculations
    • Statistics
  • Printing/Reports
    • Automatic generation of adjustment, calibration and configuration reports
    • Printout as table or graph
  • Users and passwords
    • Password protection
    • User names and rights free definable
  • 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
    • Verifiability of manipulations guaranteed at all times

 

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