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Secure Production Process in the Pharmaceutical Industry

Manufacturing plant for multinational pharmaceutical company implements version control software from AUVESY-MDT for configuration management and regulatory compliance.

Pharmazeutika Herstellung

The Initial Situation

The plant, which manufactures various pharmaceutical forms including tablets, syringes, vials, nasal sprays, and oral solids, realized that it was not effectively managing the program configurations of hundreds of PLCs of varying types and ages. The original change management process relied heavily on technical personnel to follow operating procedures to the letter in a highly regulated environment. The plant needed a change management solution that would minimize human error, increase the efficiency of technical support and maintenance, and comply with strict regulations. 


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Effective Compliance

92% of our pharmaceutical clients utilize our version control software to log all project changes, ensuring compliance with regulatory requirements.


Source: AUVESY GmbH Customer Survey, conducted in 2023, with 162 respondents.

The Solution

In researching different solutions, the plant discovered there were generic off-the-shelf configuration management solutions available on the market but that these are highly intrusive and poorly suited to production environments. They found that the drawbacks of these solutions are particularly apparent in regimented environments.

The plant ultimately selected the solution as it not only provides a centralized system that manages changes to program logic for automated controls programs and devices but also an approval and audit infrastructure that ensures compliance with FDA regulations and international pharmacopoeia standards.

The Result

The version control software from AUVESY-MDT serves as the centralized repository for all of the software versions of every PLC present in the plant’s system, both those connected over the network and standalone PLCs. Now, if a device fails, rollback and recovery data is immediately accessible. Additionally, with the comparison feature, designated personnel are notified when the program running in the device does not match the program copy on file, protecting the plant’s personnel, processes and products. The audit trail and approval support, combined with electronic approval and workflow approval, also help the plant comply with regulatory rules.


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