GEMS: A Genomic Evidence Management Framework for Regulatory Decision-Making

GEMS presents a framework for transforming genomic observations into traceable, reproducible, and auditable evidence for regulatory decision-making. It defines an eleven-stage lifecycle, six evidentiary pillars, and the Genomic Evidence Standard (GES), demonstrated through a portable food-species genomics implementation using Oxford Nanopore sequencing, LIMS integration, evidence scoring, integrity hashing, and structured reporting. The work focuses on bridging the gap between laboratory results and defensible regulatory evidence.