We implement automated analysis processes in accordance with, among other standards, the guidelines of the U.S. Food and Drug Administration (FDA, 21 CFR Part 11), ensuring that all electronic data complies with GxP requirements. Structured user management with clearly defined access rights, along with comprehensive documentation of the analysis workflow in an audit trail, ensures full traceability of all actions performed. Manipulation of the results data is impossible; all processes are documented in an audit-proof manner and are subject to rigorous version and change control procedures.

The analysis workflows are developed according to the V-Model, which optimally supports the requirements of the regulated environment and ensures the highest level of security and transparency.