Quality Software & Analysis: Keep Manufacturing in Control
Calibration management systems ensure control in highly regulated manufacturing environments.
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The need for control of manufacturing processes has never been more important than in today's regulated 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 ensuring it is correctly calibrated and maintained.
Most manufacturers are 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 calibration management software (CMS) system. Under current Good Manufacturing Practices (cGMP) and 21 CFR Part 11 Electronic Signature/Electronic Records requirements, this software application must be validated, because it is part of the quality assurance of the manufactured product.