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Automation in pharmaceutical manufacturing using zenon software platform

Automation in pharmaceutical manufacturing using zenon software platform

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The pharmaceutical industry manufactures a wide range of essential products, which has made businesses in this sector highly profitable. At the same time, pharmaceutical manufacturers face unique challenges. As one of the most heavily regulated industries, pharma must continuously monitor its compliance with local and international regulations and standards. Failure to comply with regulations can lead to unsafe products, costly fines, delays in product approval and even criminal charges.

The need to comply with regulations means that every step in the pharmaceutical manufacturing process must be traceable and thoroughly documented. In the supply chain, for example, pharmaceutical manufacturers require end-to-end transparency.

The high level of risk present in the pharmaceutical industry has made many manufacturers hesitant to move away from paper documentation and embrace the total digitalization of the manufacturing plant. As drug patents expire, however, production efficiency becomes increasingly important. At COPA-DATA, we have developed our pharmaceutical manufacturing software zenon to help companies overcome industry challenges and optimize their processes using innovative technology.

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Industry Management
Life Science & Pharmaceutical | Process Industry
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Life Sciences & Pharmaceutical solutions at a glance

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          zenon in Pharma

          zenon is a software platform that makes the engineering and automated operation of manufacturing equipment incredibly easy. The software platform can help you reach and sustain your operational goals in the pharmaceutical industry.

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            Benefits of using zenon

            The benefits of zenon for pharmaceutical manufacturers

            zenon is a software platform designed to help pharmaceutical manufacturers automate their industrial facilities and manage data more effectively. Consisting of two major elements — engineering environment for creating projects and the application level for operating projects — zenon makes controlling and executing your production line simple.

            In addition to features for designing and implementing projects, the software encompasses HMI, SCADA, reporting, alarming and more. This comprehensive design means zenon improves multiple aspects of production right out of the box. With its templates and capabilities, zenon offers the ideal HMI for pharma operations.

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            • The zenon Software Platform allows for efficient processes in pharmaceutical production, from mass production to small quantities. zenon ensures transparency and supports continuous improvement processes in the validated environment.

            • The digitization systems pharmaceutical manufacturers implement must comply with all applicable local and international regulations. To minimize the effort it takes to achieve compliance, zenon meets FDA 21 CFR Part 11 and Annex 11 of the EU GMP guidelines as standard. Both of these regulations deal with the proper use of electronic records and computer systems. As a configurable software, zenon also meets GAMP 5 Software Category 4 requirements.

            • In zenon, recipe management and ISA 88 Process Automation are characterized by a high level of user-friendliness and flexibility. Reporting and documentation are thoroughly automated in zenon. As a result, quality assurance and production can be perfectly combined, since reports and quality analyses are available at the touch of a button.

            • Building management and the monitoring of centralized technical services can be integrated into a holistic system thanks to the openness of zenon. As such, you can improve the efficiency of the entire production system.

            • zenon provides efficient project engineering in the pharmaceutical industry, coupled with reduced validation work and greater potential for innovation. GMP projects and FDA 21 CFR Part 11-compliant projects can be created right out of the box since zenon is classified as a configurable software according to GAMP 5 Software Category 4. As such, efficiency in validation is achieved during the project creation process as well as in production maintenance and expansion.

            • zenon eliminates the need for paper documentation during production, reducing the likelihood of error and making data immediately available. To ensure the traceability of changes and deletions, zenon records data with a timestamp attached. The software stores data centrally, which means you will still be able to access it if the device used to record it is lost or damaged. More secure archiving means reduced risk for your company.

            • With zenon, you can create a fully functional Runtime system without adding additional servers. By providing everything you need to optimize operations in one package, this pharmaceutical production software keeps overall cost of ownership low.

              Reducing manufacturing costs means assessing your processes, identifying inefficiencies and making targeted changes. zenon gives you easy access to the data you need to make these changes, while also reducing financial risk related to noncompliance.

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              Orchestrating SCADA Integration at Novo Nordisk Engineering

              In this session, Henrik Jerup Dolmer, Senior Automation Specialist at Novo Nordisk Engineering (NNE), shares insights into large-scale pharmaceutical manufacturing investments and the challenges of integrating equipment, ensuring compliance, and maintaining data integrity.

              As Novo Nordisk scales formulation and filling facilities globally, the company faces increasing demands for standardized equipment, seamless IT/OT integration, and efficient vendor collaboration.

              Insights
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              Life Sciences & Pharmaceutical Insights

              The art of digitalization in life sciences

              Digitalization is key to improving efficiency, ensuring GMP compliance, and enabling smarter manufacturing operations. In this session, Giuseppe Menin, Senior Director Manufacturing Industry at COPA-DATA, explores how manufacturers can use digital transformation to optimize processes, integrate legacy equipment, and build reliable, data-driven production environments.

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              zenon: Improving pharmaceutical operations and management

              In the pharmaceutical industry, zenon enables manufacturers to retire outdated processes, streamline operations and comply with regulations designed to ensure product safety and quality. At COPA-DATA, we have more than 30 years of experience developing industrial automation solutions for use in demanding fields, so you can rely on our pharmaceutical manufacturing software platform to meet your application requirements now and in the future.

              To learn more about zenon, contact us today.       

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              Industry Management
              Life Science & Pharmaceutical | Process Industry
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              Information material

              Information material

              • Pdf

                zenon 15 Highlights Pharma

                zenon15_Highlights_2025_Pharma_EN.pdf / 1.9 MB
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              • Pdf

                zenon for Life Sciences & Pharmaceutical

                Brochure

                Pharma_Brochure_2021_EN.pdf / 2.4 MB
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                FAQs

                FAQs

                Pharmaceutical manufacturers need automation that supports productivity, compliance, and long-term flexibility. This FAQ explains how SCADA, digitalization, AI, cybersecurity, and smart factory strategies apply to pharmaceutical production, and how zenon from COPA-DATA supports regulated manufacturing environments.

                • SCADA helps pharmaceutical manufacturers monitor, control, and document production processes in real time. SCADA provides centralized visibility into equipment, utilities, alarms, and process data, which supports stable operations, better traceability, and more consistent quality. In regulated environments, SCADA also helps create the foundation for auditability and data-driven process improvement.

                • Pharmaceutical companies should look for automation software that supports compliance, scalability, integration, cybersecurity, and long-term maintainability. Automation software should also help connect legacy and modern systems while reducing complexity across sites and processes. For regulated manufacturing, support for validation, auditability, and data integrity is essential.

                • Yes, zenon can support multi-site pharmaceutical production environments. zenon enables manufacturers to standardize architectures, workflows, and visibility across sites while still allowing local flexibility where needed. This supports better governance, more consistent operations, and more efficient rollout strategies.

                • Pharmaceutical automation systems must support validated operation and compliant data handling. Validation requirements typically include alignment with GAMP 5, FDA 21 CFR Part 11, and EU GMP Annex 11, depending on the application and regulated process. Pharmaceutical manufacturers also need secure user access, audit trails, documented change control, and strong data integrity across the system lifecycle.

                • The main benefits of using zenon in pharmaceutical automation include better transparency, stronger traceability, lower engineering effort, and scalable system design. zenon helps pharmaceutical manufacturers reduce complexity while supporting validated and regulated environments. zenon also supports broad connectivity and long-term flexibility across production infrastructure.

                • COPA-DATA helps pharmaceutical manufacturers connect operations, information, and compliance requirements in one scalable software environment. With zenon, manufacturers can integrate legacy and modern systems, support data integrity, strengthen traceability, and build a flexible foundation for digital transformation in regulated production.

                Our Solutions
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