Connecting the dots in life sciences.

At biomedion GmbH, we have dedicated ourselves for over two decades to the secure and GxP-compliant long-term archiving of scientific data. Our strategic focus is on the "Watcher" product family as the central brand for GxP-compliant data archiving.

We offer proven stability with Watcher 2.x, an established solution for GxP-compliant long-term archiving that has seen long-standing use in regulated laboratories and focuses on active data acquisition via APIs with full Windream integration. Our next-generation solution, Watcher 4.0, is designed for the future, featuring a modern microservice-based architecture optimized for scalability and flexibility in hybrid and cloud environments. Watcher 4.0's core feature is passive data acquisition, which allows non-invasive data collection without interfering with running systems, and it boasts significantly reduced validation effort due to its "CSV-ready" approach.

The Watcher platforms are designed to ensure data consistency, integrity, and governance, forming the foundation for trustworthy, auditable, and scientifically sound data management. Our solutions support compliance with stringent regulatory standards, including FDA 21 CFR Part 11, which mandates data integrity and reliability for electronic records and validated systems, EU Annex 11 (Computerised Systems), which applies to all computerized systems in GMP-regulated activities requiring validation and IT infrastructure qualification, OECD-GLP, and the MHRA Data Integrity Guidelines, which emphasize that data must be complete, consistent, and accurate in all forms. The Watcher platforms also implement ALCOA+ principles by design, ensuring data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available throughout its lifecycle.

biomedion GmbH is certified according to DIN EN ISO 9001:2015 for providing on-premise and cloud-based data archiving solutions and raw-data archiving services, enabling secure data storage and access in alignment with compliance standards globally.

At biomedion GmbH, we have dedicated ourselves for over two decades to the secure and GxP-compliant long-term archiving of scientific data. Our strategic focus is on the "Watcher" product family as the central brand for GxP-compliant data archiving.

We offer proven stability with Watcher 2.x, an established solution for GxP-compliant long-term archiving that has seen long-standing use in regulated laboratories and focuses on active data acquisition via APIs with full Windream integration. Our next-generation solution, Watcher 4.0, is designed for the future, featuring a modern microservice-based architecture optimized for scalability and flexibility in hybrid and cloud environments. Watcher 4.0's core feature is passive data acquisition, which allows non-invasive data collection without interfering with running systems, and it boasts significantly reduced validation effort due to its "CSV-ready" approach.

The Watcher platforms are designed to ensure data consistency, integrity, and governance, forming the foundation for trustworthy, auditable, and scientifically sound data management. Our solutions support compliance with stringent regulatory standards, including FDA 21 CFR Part 11, which mandates data integrity and reliability for electronic records and validated systems, EU Annex 11 (Computerised Systems), which applies to all computerized systems in GMP-regulated activities requiring validation and IT infrastructure qualification, OECD-GLP, and the MHRA Data Integrity Guidelines, which emphasize that data must be complete, consistent, and accurate in all forms. The Watcher platforms also implement ALCOA+ principles by design, ensuring data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available throughout its lifecycle.

biomedion GmbH is certified according to DIN EN ISO 9001:2015 for providing on-premise and cloud-based data archiving solutions and raw-data archiving services, enabling secure data storage and access in alignment with compliance standards globally.