Paperless Media Preparation Process Documentation
INTEGRA has announced that its MEDIACLAVE 10/30 media preparation systems have been upgraded to provide all the necessary tools to support the most stringent process documentation and validation needs.
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. Saving and managing process data has never been so easy. Furthermore, MEDIACLAVE 10/30 systems are equipped with Ethernet connection, allowing connection to a PC, LAN or easy integration with LIMS. As a consequence run log files can be easily and simply transferred and archived to a personal computer or data storage device of your choice.
For further information please contact INTEGRA on +41-81-286-9540 / +1-603-578-5800 or firstname.lastname@example.org.
Tags: Automation, FDA
Date Published: August 1, 2012 » company contact details