METHOD FOR CONDUCTING A BIOPROCESS

The present invention is directed to a method for conducting a bioprocess with a digital control unit (1) of a bioprocess arrangement (2), wherein the digital control unit (1) comprises a local data storage (4) and a local processor unit (5), wherein bioprocess data (16) are generated by the digital control unit (1). It is proposed, that in a data safety routine (21), a documentation routine (22) and a signing routine (24) are executed, that in the documentation routine (22), documentation data (23) are generated from the bioprocess data (16) and that in the signing routine (24), a cryptographic private key (25) is extracted from private key data (20) and the documentation data (23) are digitally signed with the cryptographic private key (25) by generating a digital signature (26) and that the documentation routine (22) is executed continuously during the bioprocess and that the signing routine (24) is executed discontinuously during the bioprocess in several signing cycles according to a signing strategy (P), which defines trigger events (ei) for initiating the signing routine (22).