Software in the life sciences industry is now a central component of the IT infrastructure to support and control processes and procedural steps. For the implementation of GxP-compliant research projects – also in the university environment – the conformity with legal requirements of software solutions must be validated in accordance with FDA specifications (21 CFR Part 11).
The goal of validation is always to ensure high quality of the data and all associated processes, as well as patient safety, as a basic requirement for the ethical acceptability of the implementation of the clinical research project.
We will be happy to support and advise you on the implementation of your pharma IT audit/ audit program with regard to legal and regulatory considerations for GCP/GLP/GMP/GDP/GVP.