Schering-Plough Moves to Paperless Calibration

Overview

FDA's compliance imperatives and guidelines for calibration set by ISPE in the GAMP Good Practice Guide for Calibration Management demand that pharmaceutical manufacturers establish robust calibration systems. Schering-Plough (Kenilworth, N.J.) installed a paperless calibration system at a number of its manufacturing facilities. The system, Prime Technologies' (West Chester, Pa.) ProCalV5, is designed to stop the avalanche of paper that results from documenting the calibration of instrumentation, devices and equipment, as part of cGMP compliance requirements. The ProCalV5 has been designed so that technicians are always presented with the correct device calibration specifications and SOPs.