Compliance with the 21 CFR Part 11

KORSCH is aware of the importance of applying control systems that allow our customers to be able to satisfy the requirements of the 21 CFR Part 11. The engineers at KORSCH have integrated third-party software into the system so that these requirements can be satisfied. This means that the customers can combine their internal procedures with the KORSCH technology to ensure satisfaction of the 21 CFR Part 11. The enclosed document summarises how KORSCH has realised the various requirements of the 21 CFR Part 11. The requirements listed in the table comprise an excerpt from the US FDA regulations known as Title 21 of the Code of Federal Regulations, Part 11, titled "Electronic Signatures and Electronic Records".

Generally, the KORSCH system in the tableting machines is controlled via an integrated programmable control system (PLC) and a personal computer (PC). Different functions within the control system can be activated and deactivated whilst the system is being configured. The information provided in the KORSCH declaration is based on the assumption that the complete output range of the control system is activated, i.e. EVENT LOG, the ALARM HISTORY and the PASSWORD LOGIN. At this time, there is no biometric possibility for personal identification.

Please read the KORSCH declaration of conformity for the 21 CFR Part 11. If you have any questions or if you require more information, please contact KORSCH. It is our mission to work together with you so that all aspects of the 21 CFR Part 11 can be fulfilled.