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Opelium GmbH specializes in CSV (Computer System Validation) and quality management. With our expertise, we support companies in achieving the highest quality standards and ensuring the compliance of their processes.

Dive into a world of innovative solutions!

Founder & CEO

Elke Wieser, MSc

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An image showing the text "eCFR" on a laptop screen, with the flag of the United States displayed above it.

eCFR - Code of Federal Regulations

Our Services

Three flagpoles with the EU flag are visible in front of a building.

EudraLex - EU Legislation

Media

A human hand stops a row of falling dominoes just before they can knock over more pieces. The hand acts as a protective barrier, preventing the progression of the chain reaction.

"Regulatory Compliant. Efficient. Your Advantage."

Maximum compliance without additional effort – our solutions help you seamlessly meet regulatory requirements while optimizing your processes. This way, you gain security, stability, and sustainable competitiveness in a demanding market environment.

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