There has never been a greater need for control over manufacturing processes than in today's 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 manufacturer's 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 cGMP's this software application must be validated, as it is a part of the quality assurance of the manufactured product. Calibration management software has evolved with the evolution of the personal computer and has increased tremendously in functionality. The typical calibration software package not only tracks equipment inventory, calibration schedules and histories, but increasingly ties into calibration procedures, contains calibration interval analysis capabilities and other advanced features. With the increased capability of this software, manufacturers have come to rely on this software. Validation provides assurance that the system is reliable and demonstrates that the system operates in a state of control.
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