Quality & Regulatory
Digital Solutions for More Transparency and Automation
Regulatory requirements are the backbone of safe and efficient drug supply in the pharmaceutical industry. They ensure that every medication reaching patients meets the highest quality standards. The industry faces complex challenges: from the preparation and submission of approval documents to the monitoring of drug production and compliant dispensing to consumers. Arvato Systems offers tailored solutions for all these regulatory demands. We partner with you in documentation, production, and the secure dispensing of your medications – for a smooth and legally compliant drug supply.
Advantages for You
Automated regulation
The reporting system along the value chain of medications to meet regulatory requirements is highly complex and often manual. AI-supported tools can massively accelerate your documentation requirements.
Transparency
With our solutions, data is available at any time and can be immediately provided for analysis. A complete monitoring of various production processes becomes possible.
Adjustment & Calibration
Automatically processed data can be used for direct process improvement. This can enhance the product quality of the medications and reduce waste.
References
Our Services for Your Success
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Arvato CSDB
Our Arvato CSDB solution unifies production lines, partners, customers, and suppliers. We support you with our professional expertise and process know-how throughout the entire serialization process. The serialization solution brings together all parties involved—from production lines to customers—and includes integration as well as all security components and process adjustments for secure medication trade.
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National verification systems
In order for the NMVOs to meet regulatory requirements, our National Medical Verification System includes services such as uploading and storing master and serialization data through the EU Hub, including connecting to the Hub for exchanging data between the respective systems. Additionally, the system processes verification requests from pharmacies and wholesalers.
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PRECTAVI®
PRECTAVI® is the innovative IT solution for digital transformation in the pharmaceutical manufacturing process. Developed by Arvato Systems, it enhances the efficiency and quality of your production through AI-supported root cause and real-time analyses as well as yield optimization. PRECTAVI® ensures regulatory compliance and process stability while promoting the automation and scalability of documentation and data analysis, thereby reducing manual work and costs.
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