A new industry focus is emerging on how digital infrastructure should be designed for cell and gene therapy—especially around chain-of-identity and chain-of-custody controls across clinical, manufacturing, and quality systems. The discussion centers on the operational risk created when therapies are patient-specific rather than batch-based, leaving compliance as a system-level architecture constraint. The piece highlights how platforms such as SAP’s Cell and Gene Therapy Orchestration (CGTO) aim to support inspection readiness and jurisdictional control, with validation requirements built in from the start. It also frames the chain-of-identity break risk as a “zero margin for error” issue rather than a downstream IT remediation problem. For CDMO and biotech operators, the underlying message is that regulatory readiness is now bound to software configuration, data lineage enforcement, and cross-system integration—areas that can directly affect auditability and release workflows as programs approach global commercialization. While not a single clinical event, the focus on orchestration reflects what therapy developers are increasingly funding: the digital layer that makes manufacturing traceable at scale.