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

Main 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-specifi c room layout

Analysis and calculation tool
Psychrometric calculations

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

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