Optimized production and compliance in the pharmaceutical industry 4.0 – partnership with secunet
In the pharmaceutical industry, IT managers, production managers and IIoT security experts face unique challenges: strict regulatory requirements, ensuring data integrity and the efficient networking of a wide range of production systems. The machine landscape often ranges from older systems to state-of-the-art machines, which makes integration and security considerably more difficult.
Using an example – a leading company in the pharmaceutical industry – we show how these challenges can be overcome in cooperation with our partner secunet. This is because the combination of secunet edge and our Orchestra data integration platform can create a future-proof and scalable solution that meets regulatory requirements and increases the efficiency and security of production.
The challenges in the pharmaceutical industry
The production of pharmaceuticals is characterized by its high level of complexity and strict data integrity requirements. Millions of data points on parameters such as temperature, pressure and mixing time must be continuously recorded, processed and backed up in order to comply with the Good Manufacturing Practice (GMP) requirements that apply in this regulated industry.
In addition, there is often a heterogeneous machine landscape: older systems require manual intervention, while state-of-the-art systems already have highly developed sensor technology. This diversity not only makes data integration more difficult, but also increases the complexity of IT/OT security. At the same time, manual documentation harbors a high potential for errors, which can result in compliance violations. In addition, there are increasing risks from cyber attacks, which make data security and confidentiality key concerns.
The integrated solution: secunet edge and our Orchestra IT/OT data integration platform
The combination of secunet edge and Orchestra addresses these challenges with a seamless integration of data collection and orchestration.
Secure data collection with secunet edge
secunet edge acts as a local data gateway that is installed directly in the production environment. It protects the machines at network level and enables the integration of older systems through retrofit solutions. In addition to the security functionality, secunet edge offers additional edge computing capabilities that allow data to be pre-processed on site and made available in real time.
This results in the following advantages for users:
Real-time analysis: production deviations are detected and rectified at an early stage.
Tamper-proof transmission: Encrypted data transmission ensures maximum security.
Flexible integration: Even older machinery can be securely networked.
Integrated firewall: Protection against cyber attacks thanks to special security modes such as layer 2 mode without IP address.
Efficient data orchestration with the Orchestra data integration platform
Once the data has been securely captured by secunet edge, Orchestra takes over its central management and integration between IT and OT. As a low-code data integration platform, Orchestra enables rapid adaptation to new regulatory requirements or production conditions – without in-depth programming knowledge.
The web-based, graphical user interface makes it possible to model interfaces intuitively and efficiently at first and to make any necessary changes independently over time, saving valuable resources. Data is processed almost in real time and integrated into central quality management systems. This creates transparency across all production steps and facilitates compliance with GMP guidelines.
Orchestra enables the following aspects:
Automated documentation: Seamless audit trails minimize compliance risks.
Flexibility through low-code: Adaptations can be implemented quickly and without programming knowledge.
Scalability: Container-based architecture (Docker/Kubernetes) ensures a flexible and future-proof platform.
Maximizing efficiency through interface templates: Reusable, modularized interfaces can be multiplied as individual services based on templates and only need to be adapted to the underlying end systems by means of configurations.
Targeted use of artificial intelligence (AI): The user can use text input to automatically create interfaces and targeted data transformations from source to target data structures, among other things.
Automated testing and creation of test reports: An integrated test functionality increases the quality of the interfaces and ensures a validated process flow.
The challenge of Pharma 4.0
Extremely strict regulatory requirements must be met in the pharmaceutical industry. The machine landscape used in production often ranges from older systems to ultra-modern devices, which makes integration and safety even more difficult.
Results: More efficiency, fewer risks
The implementation of the combined solution in the company’s production led to
Optimized production processes: Automated data acquisition and real-time monitoring increased efficiency and minimized production downtime.
Greater compliance security: GMP guidelines were reliably adhered to thanks to automated documentation and audit trails.
Cost reduction: Manual effort was significantly reduced and potential sources of error eliminated.
Transparency: Dashboards enabled continuous monitoring of production performance.
Transferable from the pharmaceutical industry to other sectors
Although the joint solution was developed specifically for the requirements of the pharmaceutical industry (Pharma 4.0), it is also suitable for other highly regulated industries such as medical technology, chemicals or food.
The flexible and scalable architecture allows for easy adaptation to industry-specific requirements, while still offering high standards in terms of data integrity, compliance and efficiency. Companies that are preparing for the digitalization of their production processes will benefit from the robust and future-proof platform.
Conclusion: A solution for the future of regulated production
With secunet edge and our Orchestra data integration platform, companies receive a comprehensive solution for secure data collection and efficient orchestration. This platform not only offers compliance with current regulatory requirements, but also creates the basis for sustainable digitalization in the pharmaceutical industry and beyond.
Thanks to continuous development, the solution is being future-proofed and expanded with new functions – from improved reporting functions to even easier integration into existing production structures. Take advantage of this opportunity to make your production more efficient, safer and future-proof.
Rica Holzmann
