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.