Our services aim at Computer System Validation and internal Quality Management necessary in a GxP-regulated environment. We verify suitability of acquired or self-developed software and qualify the respective IT infrastructure. Furthermore we challenge your GxP-Compliance via internal audits and CAPA measures.
We validate software solutions in research, pre-clinical and clinical development, Drug Safety, registration, marketing, supply chain and production – as well as ERP-software such as SAP – and test the hardware in use for suitability. Our competencies also comprise Analysis Method Assessment, Process Validation, Facility Qualification and Purification Validation. Learn more about our service modules:
Our CSV Services
secure complete GxP-Compliance for software solutions and
We support you in managing CAPAs, SOPs, in Document Management as well as in establishing complete
Use our know-how in the realization of IT-Projects
(for example Evaluation Projects and Integration Projects)