The MEDIACLAVE 10/30 systems have been upgraded to support strict process documentation.
More and more laboratories rely on electronic process documentation to avoid costs associated with paper use and excessive storage space requirements.
However, laboratories must also ensure that their electronic process documentation comply with regulatory requirements. According to FDA (21 CFR Part 11) and EU (GMP Annex 11) protocols, electronic process file must be verified with a digital signature.
New generation MEDIACLAVE 10/30 systems now provide 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.
A newly integrated USB port on MEDIACLAVE 10/30 systems allows the automated transfer of all run data log files to a flash drive.
The systems are also equipped with Ethernet connection, allowing connection to a PC, LAN or easy integration with LIMS.
