Stefan Moch
YOUR CONTACT
Stage_Quality Regulatory

Quality & Regulatory

Digital Solutions for More Transparency and Automation

Use Case
Advantages
Our services

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.

Use Case

Your challenge

In the pharmaceutical industry, strict regulations and quality standards are essential. Every step, from approval to the production of medical products, must be carefully documented and substantiated. These extensive processes impose high demands and require significant effort – although the benefits are almost exclusively for the paperwork. Nevertheless, they are indispensable for ensuring the safety and effectiveness of the products.

The target image

The information and data required for legal proof is to be processed and made reusable with the help of digital solutions. The aim is to achieve a high level of business benefit and deep process integration. Regulatory affairs should not be a paper tiger, but should create added value for the core processes of a pharmaceutical company.

Our solution

The integration of measurement data from products allows for the derivation and initiation of direct process improvements. Close monitoring and AI-supported processing of the data enable immediate adjustments to processes, stabilize product quality, and secure long-term business success. Arvato Systems provides support here from consulting to implementation.

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

STADA
Dr. Pfleger
Horus Pharma
Aenova

Our Services for Your Success

  • 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.

  • 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.

  • 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.

Your Contact for Quality and Regulatory

Stefan Moch
Stefan Moch
Expert for the Digitalization of the Pharmaceutical Industry