Poster Presentation: Digitally Secure Sequencing – Implementing Part 11 Ready NGS Data Security in a CRO Environment

Next- and third-gen sequencing are essential in GMP, GLP, and clinical settings, with FDA support for applications such as gene editing analysis and adventitious agent detection. However, meeting data integrity and 21 CFR Part 11 requirements remains a major hurdle. Many sequencing instruments lack built-in audit trails, allowing raw data to be modified without detection. Since the FDA mandates secure, time-stamped audit trails to track all changes, this gap poses regulatory risk. Further complicating compliance, bioinformatics workflows generate dynamic outputs and involve complex, multi-step analyses. These pipelines often lack robust controls and typically require formal validation. As a result, true compliance demands an integrated solution—secure instrumentation, validated pipelines, version control, comprehensive audit trails, and rigorous quality checks.