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Title: Validation Of A Calibration Management Software Package
Author: Jim Erickson
Source: 1998 Measurement Science Conference
Year Published: 1998
Abstract: There has never been a greater need for control over manufacturing processes than in todays pharmaceutical manufacturing environment. As this requirement has increased, so has the need for better management of the measurement equipment used to measure and control these processes. Fundamental to managing this measurement equipment is assuring it is properly calibrated and maintained. Most pharmaceutical manufacturers are being faced with an increasing number of instruments requiring calibration, while simultaneously reducing the resources available to maintain them. One popular method for minimizing the resources needed for maintaining instrumentation is the implementation of a commercial off-the-shelf (COTS) software package for managing the measurement equipment. Under cGMPs this software application must be validated, as it is a part of the quality assurance of the manufactured product.

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