News

Posted On: 02/02/2005

Schering-Plough Moves to Paperless Calibration

 Schering-Plough (Kenilworth, N.J.) has recently 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.

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. Historically, however, even computer-based systems have included a significant paper documentation component.

This paperwork has related to identifying and classifying instruments and devices, developing master instrument lists, calibration schedules and standard operating procedures (SOPs) that define the calibration process, setting tolerances and responses for events, qualifying calibration technicians, and implementing effective documentation, recordkeeping and calibration management systems.

The ProCalV5 has been designed so that technicians are always presented with the correct device calibration specifications and SOPs. The paperless solution performs all necessary calculations and determines event result status, according to Prime Tech sales manager, Bernard Williams. Technicians in the field carry notebook or tablet PCs and even the latest documenting process calibrators and regularly input their results to the system. Calibration data is stored and easily accessible to all of those who need it.

A free demo of the software may be found here.