This white paper provides you with required knowledge related to the involved regulatory authorities and scientific technologies and disciplines: Next Generation Sequencing (NGS), Bioinformatics and Computer System Validation (CSV).<p><p>Dr. Hon Q. Tran, Stefan Borutzki, Dr. Izabela Fabianska, Benjamin Richter, Heiko Julius, Christoph Alarich, Guido Lippert, Guido Schulze, Stefan Schrapel, Dr. Dietmar Mayer