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
Viewing of measured values/Monitoring
Archiving of data
Display of the measured values
Analysis and calculation tool
Users and passwords
Electronic record, electronic signature, audit trail
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