Geminyx FDA 21CFR Version
GEMINYX FDA 21CFR PART 11 CONFORMING The Geminyx 21CFR Part 11 conforming version completely fulfils the strict security guidelines of the FDA: Integrated user management, whereby individual user and access rights are installed by the administrator Individual allocation of each system to the corresponding user Complete open audit trail: Each action is automatically recorded and stamped with user name and time Fully open revision management: Every calculated result can be reproduced with all its elements simply using the mouse Data security is ensured with coded integration into a relational database which prevents any manipulation or deletion of data sets Electronic signature   COMBINATION POSSIBILITIES Configurable as workstation or also client / server Alongside the local Jet database the data can also be stored on a central database server Compatible with Oracle and Microsoft SQL servers	Geminyx FDA 21 DATA SHEET (PDF)
Article Description 78-279000 Geminyx Software – Basic Version 21CFR11 78-279010 Geminyx 21CFR11-Package 1-DAD (incl. USB A/D-converter) - for 1 system 78-279011 Geminyx 21CFR11-Package 2-DAD (incl. USB A/D-converter) - for 2 systems 78-279012 Geminyx Integration Pack 21CFR11 (incl. USB A/D-converter) - for 4 channels 78-279002 Geminyx 21CFR11 Reprocess Version Example for complete single system Description 78-279010 Geminyx 21CFR11-Package 1-DAD (incl. USB A/D-converter) - for 1 system PC-TOP Industrial PC with QuadCore Processor, validated with Geminyx Software 78-278605 Industrial PC with QuadCore Processor, validated with Geminyx Software Inst-2 Installation client / server and training on-site Upgrades from Geminyx standard systems to 21CFR11 versions Description 78-279013 Geminyx Reprocess 21CFR11 Upgrade from Geminyx standard Reprocess version 78-279014 Geminyx 21CFR11 Upgrade from Geminyx single system 78-279015 Geminyx 21CFR11 Upgrade from Geminyx dual system 78-279016 Geminyx 21CFR11 Upgrade from Geminyx Integration Pack standard system Upgrades from Kontron / Bio-Tek KromaSystem 2000® / KromaSystem 3000® Description 78-279018 Geminyx 21CFR11 Upgrade from KS2000 single system 78-279019 Geminyx 21CFR11 Upgrade from KS2000 dual system 78-279020 Geminyx 21CFR11 Upgrade from Kroma Integration Pack® 78-279017 Geminyx 21CFR11 Reprocess Upgrade from KS2000 Reprocess       E-Mail - REQUEST