When is an Alarm an Alarm

Overview One common question asked by companies with rooms, buildings, or other enclosures with Heating, Ventilation, and Air Conditioning (HVAC) requirements is, “At what point does an excursion outside the specified range need to be logged?” A few of the most commonly monitored HVAC conditions in pharmaceutical manufacturing are differential pressure (DP), humidity, and temperature, […]

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Software as a Service (SaaS)

Overview Software as a Service (SaaS) is growing in demand more each year with the evolution of cloud services and the lack of capital budgets for on-premise deployments. Software as a service features a complete application offered as a service on demand. (Cloud Validation Solutions) A single instance of the software runs on the cloud […]

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Dominance and Validation

Introduction The purpose of this white paper is to provide the life science industry with an approach to process validation that provides a method to identify what variables exist in the process, which variables exhibit dominance, and control methods to minimize process variability using the concepts of Dominance as described by Dr. Juran[1]. Problem Statement […]

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How Many Sensors?

Overview One of the most commonly asked questions posed by companies who have chambers, rooms or buildings that have critical temperature and/or humidity requirements is, “How many sensors will be needed to map my chamber?”  This paper will explore considerations and mapping strategies associated with product storage chambers. Temperature and humidity mapping provides evidence that a […]

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