Ask any life sciences quality leader where their biggest compliance headaches originate, and you might expect them to point to their quality management system (QMS), their standard operating procedures (SOPs), or their document control infrastructure. Multiple regulatory frameworks – 21 CFR 211, the Quality Management System Regulation (QMSR), and EU GMP Annex 11 – impose overlapping documentation requirements on manufacturing operations, and paper-based environments are poorly equipped to satisfy all of them at once. When operators execute batch records within an electronic system, compliance shifts from something people have to remember to something the system enforces by design: