You are an IT manager, production manager or IIoT security expert in the pharmaceutical industry – someone who is responsible for ensuring that production runs smoothly and safely. Their task is not only to manufacture high-quality products, but also to comply with strict regulations, ensure data integrity and efficiently connect different production systems. These systems range from old machines to state-of-the-art systems.
One example of these challenges is a leading company in the pharmaceutical industry. Millions of data points on critical parameters such as temperature and pressure must be reliably recorded and documented in order to meet the strict requirements of Good Manufacturing Practice (GMP).
But the challenges do not end with data collection. Different systems must communicate seamlessly with each other and the security of the data must never be compromised. This requires more than a standard solution – an intelligent platform that both increases efficiency and overcomes all regulatory hurdles.
This is exactly where the combination of secunet edge and soffico Orchestra comes in. This combined solution is aimed directly at professionals like you – IT managers and those responsible for security in production. The solution enables secure data capture, flexible orchestration and offers the necessary scalability to meet future challenges. Not only can you ensure compliance, but you can also make your production processes more efficient and minimize risks in the long term.
Challenges of the pharmaceutical industry: mastering complex data landscapes
In the production of pharmaceuticals, even the smallest deviation can have a significant impact on product quality. This is why ensuring data integrity is so important. Companies in the pharmaceutical industry are not only faced with the challenge of manufacturing products of the highest quality, but also of ensuring that data is continuously recorded, processed and secured in order to meet strict regulatory requirements.
The machine landscape in production is often very heterogeneous. While some machines have state-of-the-art sensors, other devices are outdated and require manual intervention. This variety of different devices significantly increases the complexity of data integration, especially for large fleets of often several thousand devices, which makes the management of these devices challenging. secunet’s Content Central Management App (CMA) enables security settings and protocols to be harmonized efficiently and secunet edges to be managed centrally to ensure smooth IT/OT integration. The production lines of the pharmaceutical company in this example are equipped with numerous sensors and control systems that record critical production parameters such as temperature, pressure, mixing time, viscosity and filling volume. This data is crucial for quality control and ensuring the concentration of active ingredients.
In addition, quality testing devices monitor the physical and chemical properties of the products, such as the concentration of active ingredients and shelf life. Production machines such as mixers, granulators, tableting presses, filling and packaging machines are central sources for recording process data. These machines are controlled by automation systems such as PLC, SCADA and DCS, which enable production processes to be monitored and controlled.
Millions of data points are generated every day, which need to be reliably recorded and integrated into a consistent structure to ensure efficient monitoring and analysis. Reliable data integration is crucial for ensuring production quality and increasing the efficiency of operational processes.
In addition, all production steps must be documented in a traceable manner in order to meet the requirements of Good Manufacturing Practice (GMP). Manual documentation processes harbor a high risk of errors and can lead to compliance violations. The increasing networking of production systems also increases the risk of cyber attacks, which makes data security and confidentiality a key concern for the industry. Cybersecurity is therefore an integral part of production planning and execution.
An integrated solution for Pharma 4.0 - Seamless, secure data collection and orchestration
Secure data capture with secunet edge
secunet edge acts as a local data gateway in the production environment of the leading company in the pharmaceutical industry and ensures that the data is secured and processed correctly from its source. secunet edge is installed at every production site and acts not only as a security gateway, but also as an edge computing device. Machines are protected at network level and older machines can also be smoothly integrated into modern IT/OT environments using retrofit solutions. This seamless integration is crucial for efficiently and securely networking both older and new machinery.
Thanks to the edge computing functionality of secunet edge, data can be pre-processed directly on site, enabling the rapid provision of real-time data for analysis tools and thus supporting prompt reactions to production deviations. The relevant process information can be transmitted and viewed in Orchestra at any time in order to provide analysis applications with the required data. This is important in order to identify potential problems at an early stage and ensure product quality. Encrypted and tamper-proof data transmission ensures that data is protected throughout the entire process.
The ability to analyze in real time means that process deviations can be detected and rectified immediately, reducing production downtime and increasing productivity. secunet edge also offers an integrated firewall and special security modes, such as Layer 2 mode without a dedicated IP address, which ensures additional security despite the machines remaining in their original network configuration.
Efficient data orchestration with the Orchestra low-code data integration platform from soffico
Once the data has been securely recorded, Orchestra takes over its central management and integration. As a low-code platform, Orchestra enables rapid adaptation to changing regulatory requirements or new production conditions – without in-depth programming knowledge. The low-code approach makes it possible to configure connectors even without programming experience. Thanks to a graphical interface and intuitive (graphical) data mapping, users can make changes themselves, saving valuable company resources. This flexibility and agility are particularly valuable in a dynamic production environment in which adaptability is a key success factor.
Orchestra processes the recorded production data almost in real time and integrates it directly into the pharmaceutical company’s central quality management system. This enables seamless monitoring and documentation of all production steps, which is crucial for compliance with GMP requirements. The solution aggregates data from different production lines and ensures that all relevant information can be displayed in a standardized dashboard, providing production managers and quality managers with comprehensive transparency.
The automated documentation of all changes to the data ensures that the GMP guidelines are adhered to. Audit trails offer transparent traceability, which significantly reduces the risk of compliance violations. Orchestra can automatically document interfaces for efficient interface management and enable all necessary maintenance functions through the Orchestra Monitor.
The solution also supports reporting by storing data in an auditable format and documenting all changes to meet compliance requirements. Orchestra also ensures that data is encrypted and transmitted in a tamper-proof manner throughout the entire manufacturing process, thus meeting the requirements of Good Manufacturing Practice (GMP) at all times.
Technical details: Flexible architecture to meet high requirements
The combination of secunet edge and the Orchestra low-code data integration platform from soffico is based on a flexible technical architecture. secunet edge uses edge computing to analyze data directly at the source and enable quick decisions. Encrypted communication ensures that data remains protected throughout the entire process. The platform is designed in such a way that it can be easily expanded using a scalable architecture without disrupting ongoing operations.
By using a Docker-based architecture, the platform can be flexibly expanded. This is particularly important in the dynamic pharmaceutical industry, where new requirements constantly have to be met. Orchestra runs in a secure Docker environment that provides an additional layer of protection for the operating system. Docker’s container technology makes it possible to provide new functions and updates without disrupting ongoing production processes. This means that the platform is always up to date and can respond to future challenges.
Results and benefits: Efficiency and compliance ensured
The implementation of secunet edge and Orchestra in the production environment of the leading company in the pharmaceutical industry has brought significant improvements. The automation of data collection and processing optimized the entire production process and ensured that the strict regulatory requirements were met. The continuous analysis of the data makes it possible to identify potential problems at an early stage and take appropriate measures, resulting in less downtime and more stable production. This not only increases efficiency, but also the cost-effectiveness of production.
The automated documentation of all relevant data facilitates compliance with GMP guidelines and significantly reduces manual effort. This minimizes the risk of compliance violations and ensures a high level of security during audits. Another important feature is batch management, in which all production steps are documented for each batch to ensure complete traceability. The use of dashboards makes it possible to continuously monitor production performance and take immediate action if necessary. This ensures the quality of the end products in the long term.
Transferability to other sectors
Although this solution was developed specifically for the pharmaceutical industry (Pharma 4.0), the benefits can also be transferred to other highly regulated sectors. Industries such as medical technology, the chemical industry or food production – wherever data integrity, compliance and efficient automation are important – can benefit from secunet edge and soffico Orchestra.
The scalable architecture enables flexible adaptation to different production requirements and ensures that companies are also well positioned for future challenges. The flexibility and adaptability of the platform make it a future-proof investment that can be seamlessly integrated into existing production structures.
Conclusion: Future-proof solution for regulated production
secunet edge and Orchestra from soffico offer a comprehensive solution for secure and efficient data collection and orchestration in the pharmaceutical industry. This platform not only ensures compliance with current regulatory requirements, but also creates a solid foundation for the sustainable digitalization of other regulated industries. Automated data acquisition, real-time monitoring and ensuring data integrity help to optimize production processes and make them future-proof.
The continuous further development of the joint solution aims to offer additional functions for efficient automation and data security. This includes new modules to improve data integrity, enhanced reporting functions and even easier integration into existing production landscapes.
