Revolutionizing Computerized System Validation for NGS-Based Assays with Genedata Selector

October 24, 2023

Efficient validation of assays in accordance with Good Manufacturing Practice (GMP) is critical for precision and reproducibility in drug development and manufacturing. Next-generation sequencing (NGS) is increasingly being used in the pharmaceutical industry as an alternative to traditional assays like for adventitious agent detection (AAD). However, NGS systems must be validated before deployment in GxP environments. 
Genedata Selector^® offers enterprise software that enables biopharmaceutical organizations to perform NGS-based assays in-house. This platform simplifies Computerized System Validation (CSV) and becomes a single source of truth across the NGS instruments and assays within the organization.