Schering-Plough Moves to Paperless Calibration
By Pharmamanufacturing.com
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.
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