As laboratories transfer to electronic process documentation to avoid costs associated with paper use and excessive storage space requirements they must ensure that their electronic process documentation comply with regulatory requirements. The Mediaclave 10/30 system provides the feature of digitally signed log files as a safeguard against tampering with downloaded files. The signed log files fully comply with FDA (21CFR Part 11) and EU (GMP Annex 11) directives requirements for electronic process documentation. An integrated USB port on MEDIACLAVE 10/30 systems allows the automated transfer of all run data log files to a flash drive. The system is equipped with Ethernet connection, allowing connection to a PC, LAN or easy integration with LIMS and run log files can be easily and simply transferred and archived to a personal computer or data storage device of your choice.
INTEGRA Biosciences Corporation