THE INCREASING reliance of laboratories on electronic documentation brings with it both penalties and bonuses. A move towards paperless status has advantages in cost and reduced environmental footprint, but can add complexity to regulatory requirements.
One example of this is the requirement of the US Food and Drug Administration (FDA) 21 CFR Part 11, and the European Union GMP Annex 11 protocols, for digital process files to be verified with a digital signature.
Integra reports that it has upgraded its Mediaclave 10/30 media preparation systems to provide the tools necessary to support even the most stringent process documentation and validation needs.
New Mediaclave 10/30 systems now provide digitally-signed log files, which comply with FDA and EU requirements, as a safeguard against files being tampered with.
A newly integrated USB port on the systems allows the automated transfer of all run data log files to a Flash drive. Mediaclave 10/30 systems are also equipped with ethernet connection, allowing connection to a PC, Lan, or Lims.
This means that the new tamper-proof run log files can be easily transferred and archived in practically any data storage system.