"If it isn't documented, it didn't happen."
A key success factor for a CCS is a gapless documentation. Just talking about 21 CFR Part 11 or audit trail is not sufficient anymore. It’s more about the overall lifecycle of data generated, about raw data, meta data et cetera.
Due to the increasing demands in data management and data integrity e.g. ALCOA or ALCOA+ principle and other regulations, the effort for compliant documentation is permanently increasing. A serious number of concerns and warning letters from the FDA are related to data integrity violations.
To avoid these concerns, automation is an important part of the documentation strategy. Through automation of key process steps, fully compliant documentation systems can easily be implemented. Avoiding manual processes releases the user from time consuming and error prone manual documentation.
With the AQU@Sense MB, one of the last manual procedures, the bioburden analysis, can now be fully automated. No manual sampling, no manual sample preparation makes this tool the ideal solution for fully automated documentation. In combination with the electronic control features of the AQU@View, all data are collected, logged and visualized at one point and can be exchanged with the laboratory information system or any other control unit.