Regulatory surveillance is ongoing oversight, monitoring, or review used to assess whether regulated products, processes, records, or organizations continue to meet applicable requirements. In manufacturing, it commonly refers to activities by regulators, customers, or authorized oversight bodies, as well as internal monitoring designed to detect compliance risks before formal findings occur.
Regulatory surveillance may include inspections, review of quality records, monitoring of nonconformance trends, follow-up on corrective actions, supplier oversight, reporting obligations, or review of post-release product performance. In digital manufacturing environments, it often depends on controlled records, audit trails, traceability data, version history, and evidence from systems such as MES, QMS, ERP, or document control platforms.
The term should not be confused with general shop-floor monitoring or production analytics. Those activities may support regulatory surveillance, but regulatory surveillance specifically concerns oversight against external requirements, approved procedures, or defined compliance obligations. It also does not by itself imply certification, validation, or acceptance by an authority.