Bioprocess Data Documentation With Discontinuous Signing
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Solution Overview
Problem
The existing methods for ensuring data integrity in bioprocesses are complex and inefficient, particularly in managing the signing of bioprocess data across multiple laboratory units and compliance procedures, leading to increased complexity and reduced efficiency.
Innovation Solution
A method involving a digital control unit that segments bioprocess data into sets and signs them in predefined cycles using trigger events, employing asymmetric cryptography with a cryptographic private key, ensuring data integrity while minimizing data processing requirements and hardware additions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If data signing is performed continuously for all bioprocess data, then data integrity is ensured, but data processing complexity and time consumption increase significantly
Solution Approach 1:
The patent segments bioprocess data into discrete data sets that are signed individually at specific intervals rather than continuously signing all data. This segmentation approach maintains data integrity for each data set while significantly reducing the overall signing complexity and time consumption compared to continuous signing of all data streams.
2Reliability
If external signing units are added to validate data integrity, then compliance requirements are met, but device complexity increases
Solution Approach 1:
The patent implements a signing strategy within the existing digital control unit that enables it to perform multiple functions: continuous data generation, periodic data signing, and integrity validation. This multi-functionality eliminates the need for separate external signing units while meeting compliance requirements, thereby maintaining data integrity validation without increasing device complexity.
3Reliability
If manual signing initiation is required for each data set, then data integrity is maintained, but operational efficiency decreases
Solution Approach 1:
The patent implements a predefined signing strategy that automatically initiates signing operations based on predetermined criteria such as time intervals or data set completion. This preliminary action approach ensures data integrity is maintained through systematic signing while eliminating manual intervention, thereby significantly improving operational efficiency and productivity.
4Reliability
If comprehensive documentation is generated for compliance procedures, then regulatory requirements are satisfied, but data processing requirements increase
Solution Approach 1:
The patent extracts and signs only the essential documentation data representing bioprocess data sets rather than processing and signing all raw data. This extraction approach generates comprehensive documentation for compliance procedures while significantly reducing data processing load and energy consumption by focusing only on the critical information required for regulatory satisfaction.
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 bioprocess data are generated by the digital control unit. It is proposed, that in a data safety routine, a documentation routine and a signing routine are executed, that in the documentation routine, documentation data are generated from the bioprocess data and that in the signing routine, a cryptographic private key is extracted from private key data and the documentation data are digitally signed with the cryptographic private key by generating a digital signature and that the documentation routine is executed continuously during the bioprocess and that the signing routine is executed discontinuously during the bioprocess in several signing cycles according to a signing strategy, which defines trigger events for initiating the signing routine.