FDA investigators closely examine gaps between documented QMS procedures and real shop-floor activity. Effective quality control in production process environments now depends on real-time visibility into product location and status.... Read More
Author: LocaXion
Under the new QMSR requirements, controlling FDA nonconforming product is a vital compliance step. Clear identification, proper documentation, physical segregation, and defined disposition are essential to prevent accidental use. LocaXion... Read More
Managing FDA nonconforming product is a key compliance requirement under the updated QMSR framework. Products must be clearly identified, documented, segregated, and properly dispositioned to avoid accidental use. LocaXion explains... Read More
Most ISO 13485 medical devices quality management systems overviews explain documentation requirements, but they often overlook the FDA QMSR demand for real, provable control. Paper records alone cannot stop silent... Read More