Bioprocess Data Signing via External Units to Prevent Manipulation
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Solution Overview
Problem
Existing bioprocess data integrity is vulnerable to manipulation, particularly in biotechnological and biopharmaceutical processes, necessitating improved methods to ensure data integrity with low effort.
Innovation Solution
A digital control unit with a local processor and storage unit initiates a signing routine using an external signing unit, employing asymmetric cryptography to generate digital signatures for bioprocess data, ensuring data integrity by controlling the signing process and minimizing opportunities for manipulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing signing methods are used to ensure data integrity, then data manipulation is prevented, but the system remains vulnerable to manipulation within the bioprocess laboratory
Solution Approach 1:
The system segments the signing process into distinct components: a signing routine that is initiated by the digital control unit but executed externally. This separation isolates the critical signing function from the potentially compromised laboratory environment, enhancing data integrity without requiring complete system redesign
Solution Approach 2:
An external signing unit acts as an intermediary between the bioprocess data and the signing function. This intermediary executes the signing routine outside the vulnerable laboratory environment, providing an additional layer of protection against manipulation while maintaining system functionality
2Reliability
If complex technologies like distributed ledger technology are implemented, then data integrity is enhanced, but hardware and system complexity increases
Solution Approach 1:
The critical signing function is extracted from the complex distributed ledger technology framework and implemented as a standalone routine that can be executed by simple external units. This extraction achieves data integrity protection without requiring the full infrastructure of complex blockchain systems
Solution Approach 2:
The system uses simple, inexpensive external signing units that can be easily deployed and replaced if needed, rather than investing in complex, expensive distributed ledger infrastructure. The signing routine itself serves as a lightweight, disposable solution that achieves the security goal without heavy hardware requirements
3Loss of information
If existing signing methods are used, then data documentation is maintained, but manipulation opportunities remain within the laboratory
Solution Approach 1:
The signing routine is initiated by the digital control unit before the data leaves the controlled environment, establishing an early seal on the data integrity. This preliminary signing action creates a trusted reference point that prevents subsequent manipulation while maintaining complete data documentation
Solution Approach 2:
The system implements a feedback mechanism where the digital control unit initiates the signing routine based on the bioprocess data, and the execution status is fed back to confirm successful signing. This closed-loop approach ensures both documentation is maintained and manipulation is prevented through verified signing execution
Data Source
AI summary
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 for sending and receiving bioprocess control data, wherein bioprocess data are generated by the digital control unit, wherein a bioprocess control routine is executed by the local processor unit to control the bioprocess, wherein in the bioprocess control routine, the bioprocess data are generated by the digital control unit from actuator data and/or sensor data and/or user control command data. It is proposed that a signing routine is initiated by the local processor unit in the data safety routine to be executed by an external signing unit(s).