Quality & Compliance
Validation, GxP and compliance for regulated industries — documented, traceable and audit-proof.
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GAMP 5-compliant validation of your systems — risk-based and efficient.
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QM systems that work in daily practice, not just on paper.
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Preparation and support so audits become routine, not a risk.
FAQ
CSV is the documented verification that an IT system or process consistently and reproducibly meets its intended requirements — mandatory for regulated industries such as pharma and medtech under FDA 21 CFR Part 11 and EU GMP.
GxP (Good Practice) covers regulatory requirements for quality and traceability in life-sciences industries. In an IT context it means validated systems, complete audit trails and compliance-ready documentation.
Qudits AG performs gap analyses, produces audit-ready documentation and supports companies on site during regulatory inspections and supplier audits — in medtech, pharma and public administration.
Sandra Weniger-Niederberger
Associate Partner
Let’s talk about your project — informally and concretely.
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