Pharmaceutical manufacturing management software

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.

 

zenon Software Platform in Pharmaceutical

 

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.

 

A comprehensive software platform

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.

 

 

Easy compliance with regulations

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.

 

Flexibility and quality assurance in production

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.

 

Efficiency through the integration of centralized technical services

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.       

 

Reduced validation work

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.

 

Improved data storage

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.

 

 

Lowered manufacturing costs for pharmaceutical companies

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.

 

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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Our Pharmaceutical Insights

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