Method for conducting a bioprocess

A method for conducting a bioprocess with a digital control unit of a bioprocess arrangement,

• wherein the digital control unit comprises a local data storage and a local processor unit,
• wherein the digital control unit comprises a bioprocess interface that sends and receives bioprocess control data,
• wherein the bioprocess interface comprises an actuator interface for sending actuator data to at least one actuator for influencing the bioprocess, the method comprising:
• receiving, with a sensor interface of the bioprocess interface sensor data related to the bioprocess from at least one sensor,
• generating, by the digital control unit, bioprocess data,
• displaying to a user at least part of the bioprocess data and receiving user control command data with a user interface of the digital control unit,
• executing a bioprocess control routine by the local processor unit to control the bioprocess,
• wherein in the bioprocess control routine, the sensor data are received by the digital control unit from the sensor,
• wherein in the bioprocess control routine, the actuator data are generated by the digital control unit based on the user control command data and/or the sensor data and the actuator is controlled by the digital control unit by sending the actuator data to the actuator thereby influencing the bioprocess,
• wherein in the bioprocess control routine, the bioprocess data are generated by the digital control unit from the actuator data and/or the sensor data and/or the user control command data, wherein private key data are stored in an external signing unit,
• that a data safety routine is initiated by the local processor unit,
• that a documentation routine is initiated by the local processor unit in the data safety routine to be executed by the local processor unit or an external documentation unit, that in the documentation routine, documentation data are generated from the bioprocess data by the local processor unit or the external documentation unit,
• that a signing routine is initiated by the local processor unit in the data safety routine to be executed by an external signing unit and that in the signing routine, a cryptographic private key is extracted from the private key data by the external signing unit and that the documentation data are digitally signed by the external signing unit with the cryptographic private key by generating a digital signature.