Navigating the Do's and Don'ts of Computerized System Validation (CSV) for In-House NGS-Based Adventitious Virus Detection Assays

April 11, 2025

Next-generation sequencing (NGS) has emerged as a highly sensitive method for viral safety testing, reflected in the ICH Q5A (R2) guideline, and is increasingly used in GMP environments. However, validating NGS viral safety assays in-house is a complex process that requires knowledge of how to handle, analyze and report data. Computerized System Validation (CSV) is a crucial part of the assay validation process to guarantee data integrity, product quality, and patient safety.  

This poster covers best practices for efficient CSV planning and execution. To succeed, key stakeholders must work seamlessly to ensure that the essential elements of the computerized system qualification process are met. We will outline the optimal implementation process to ensure that the computer system for NGS-based virus safety assays works as required, fits the intended purpose, and meets the user’s needs and timelines.