In today’s high throughput, data-intensive laboratory environment the principles of QbD, data completeness and integrity should support the functions and operating ethos of any Quality Assurance/Quality Control (QA/QC) operation. Implement a comprehensive, intelligent informatics infrastructure and the job becomes less daunting. This laboratory-focused digital infrastructure is likely to be founded on laboratory information management system (LIMS) functionality to orchestrate test scheduling, manage samples, and automate critical processes. Today’s high-end LIMS will also acquire and channel analytical data directly from measurement and testing instrumentation, offer advanced analytics to support trend identification, and highlight nonconformity and out-of-specification results.