In the Pharma and Radiopharma industry, data management is no longer just an operational necessity—it is the core of the entire production process.
Increasingly stringent regulations, complex corporate infrastructures, and the need to ensure efficiency and continuity are driving companies to rethink their approach.
In this context, Tema Sinergie introduces a new Hardware and Software architecture: a new workflow paradigm in which data becomes the central element upon which the entire production process is built.
Data at the Core: A New Paradigm
For years, the industry approached automation starting from the production process, treating data management as a secondary aspect. Today, this logic is being reversed:
From:
“Production drives data management”
To:
“Data management drives production”
This shift in perspective enables the creation of a more robust, secure, and scalable infrastructure, reducing operational risks and improving overall production efficiency.
The Starting Point: Redesigning the Data Journey
In an automated system, every piece of information is generated, transferred, and stored within a complex ecosystem that includes:
- Production lines
- SCADA/HMI
- Batch control & recipe management
- MES, ERP, BMS
- Corporate servers and IT systems
Within our architecture, all machine-generated data resides directly on the customer’s server, inside a secure and centralized virtual machine.
Operators interact through a Thin Client: a lightweight terminal with no local logic or storage capabilities. This approach not only eliminates the risks associated with on-board servers and enhances protection against unauthorized access, but also drastically reduces production downtime. The Thin Client can be considered a simple hardware component, easily replaceable without impacting the system: it can be disconnected and replaced in a matter of minutes, even by keeping spare units in stock. An additional key advantage is the complete elimination of data loss risks, as no data is stored locally on the machine.
Data Life Cycle: sicurezza e controllo in ogni fase
Building smarter machines means managing the entire data life cycle. Our approach is based on four fundamental pillars:
Data Integrity
Data Integrity is the foundation of the entire architecture. It ensures that all data remains complete, accurate, consistent, and protected throughout its entire lifecycle, from generation to long-term storage. In the Pharma and Radiopharma industries, this means operating within a highly demanding regulatory framework. Our solution is therefore designed to fully comply with key international standards such as FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP5 guidelines, ensuring that every piece of information maintains the highest level of quality and reliability.
Traceability
Traceability is not only a regulatory requirement but also a critical element for understanding the full journey of data. Within our architecture, it is always possible to reconstruct who performed a specific action, when it was executed, from which workstation, with which permissions, and for what purpose. This level of detail is achieved through careful management of data acquisition, communication, visualization, and centralized storage. The entire process is supported by electronic signatures, access control systems, and advanced reporting tools, enabling a complete and transparent historical view of all activities.
Disaster Recovery
A modern system must ensure operational continuity even under critical conditions. For this reason, our approach to disaster recovery goes far beyond simple data restoration, providing a complete infrastructure capable of responding rapidly to failures or interruptions. Backups are performed automatically and centrally, enabling fast recovery that is fully independent of the underlying hardware. Redundant servers in hot standby mode ensure immediate failover when needed, while the use of Thin Clients eliminates any risks associated with local machine logic.
An additional key aspect lies in the management of virtual machines, which are owned and directly administered by the customer’s IT department. This allows recovery procedures to be carried out independently, without waiting for supplier intervention. The result is a significant reduction in downtime and the ability to quickly restore operations, ensuring full continuity of production activities
Strategic Choice: zenon Software Platform by COPA-DATA
To support such an advanced architecture, it was essential to adopt a SCADA system that is reliable, modern, and fully aligned with industry regulatory requirements. Our choice fell on zenon, a well-established software platform in the Pharma sector, capable of seamlessly integrating automation with corporate information systems. zenon stands out thanks to its GAMP5 Category 4 classification, meaning the software is already validated and therefore significantly reduces validation time. Its certified standard modules, intuitive and multilingual interface, and high operational stability make it ideal for ensuring production continuity. Furthermore, its ability to integrate easily with higher-level systems such as MES, ERP, and BMS completes a technological ecosystem that is flexible, secure, and scalable.
Tangible Benefits
Adopting our HW/SW architecture means implementing a modern, robust system designed for the future. Companies benefit from built-in compliance embedded in every component, simplifying daily operations and reducing the risk of non-compliance. Data security is significantly enhanced through an infrastructure designed to prevent vulnerabilities and protect critical information. Validation timelines are also considerably reduced, along with associated costs and commissioning time. Operational continuity is improved thanks to advanced disaster recovery strategies and an architecture free from local logic dependencies. All of this is combined with natural system scalability and simplified maintenance, fully integrated with corporate IT infrastructures, enabling a higher level of integration between production lines and enterprise systems.
An Architecture Designed for the Future
The Pharma and Radiopharma industries are evolving rapidly. Remaining competitive requires more than automation—it demands systems designed to adapt to future technologies while ensuring high availability, maximum security, and full control over data.
Our new HW & SW architecture embodies this vision: an ecosystem designed to connect machines to the digital core of the company, transforming data into value and paving the way for smarter, safer, and more sustainable production.