Industries & Application Areas

Opelium GmbH supports companies in the validation of computer-based systems, quality management, and risk management – securely, efficiently, and in regulatory compliance. Our expertise spans across numerous industries and application areas.

Our expertise in CSV, quality management, and risk management is in demand across various industries. Here is an overview of the key application areas:

1. Pharmaceutical Industry

Ensuring regulatory compliance (e.g., GxP and FDA 21 CFR Part 11) through validated IT systems to guarantee product quality and patient safety.

2. Medical Technology

Validation of computer-based systems and quality processes to comply with MDR and ISO 13485 – crucial for approval and marketability.

3. Biotechnology

Controlled processes and data integrity through quality-assured systems – from research to production.

4. Chemical Industry

Risk analyses and validated systems ensure safe processes and compliance with environmental and safety standards.

5. Food Industry

Implementation of QM and HACCP systems to ensure food safety and traceability throughout the supply chain.

6. Cosmetic Industry

Efficient quality management and computer-based documentation help comply with regulatory requirements according to the EU Cosmetics Regulation.

7. Hospitals & Laboratories

Validation of laboratory information systems (LIMS), electronic patient records (EHR), and QM systems to comply with medical standards.

8. IT & Software Development

Validation of software solutions in regulated environments, such as for cloud services, data integrity, and SaaS applications.

9. Logistics & Supply Chain

Risk analyses and quality-assured processes for the storage, transport, and distribution of sensitive products, such as pharmaceutical cold chains.

10. Energy & Environmental Engineering

Risk-based system analyses and QM strategies for the sustainable and safe management of technical systems and environmental management systems.