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Using the ISPE’s GAMP Methodology to Validate ...

Using the ISPE sGAMP Methodology to Validate Environmental Monitoring System SoftwareTESTDOCUMENTSUSER REQUIREMENTSDETAILED SPECIFICATION DOCUMENTSFUNCTIONALSPECSB211370EN-A2 IntroductionContinuous Monitoring Systems (CMS) are used in the pharmaceutical industry to detect out-of-specification (OOS) conditions in manufacturing, processing and distribution environments. These modern, Web-based monitoring applications can also send email alarms to notify personnel to take corrective action before OOS conditions, such as extreme temperature or humidity, can have a negative effect on product quality and safety.

take corrective action before OOS conditions, such as extreme temperature or humidity, can have a negative effect on product quality and safety. ... the GAMP methodology as a reasonable and systematic guide to ensure your monitoring system software performs as expected throughout its life

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  Methodology, Action, Corrective, Corrective action

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