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9 Things you need to know about Continuous Monitoring Systems in FDA-Regulated Environments

9 Things you need to know about Continuous Monitoring Systems in FDA-Regulated Environments
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know about Continuous Monitoring Systemsi

If you work in a life science company or any company that is regulated by the FDA, you know that you will have to monitor important environmental parameters (e.g. temperature, relative humidity) at locations in your facility. While the concept of monitoring is simple, a deeper understanding of how your monitoring system works can have a big impact on the success of your business, especially if regulators find your monitoring systems to be unsatisfactory. The following application note looks at several different approaches to monitoring and outlines nine crucial evaluation points that will...

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Short History of Monitoring Devices Early monitoring systems were freezer with pen and paper records. Unfortunately, if the freezer fails, the problem isn't discovered until the next time someone checks there is no way to know what has happened to what is being stored in the freezer and for safety's sake, you have to assume the worst. In 1888 William Henry Bristol invented the chart recorder and J.C. Stevens patented the first environmental of chart recorders improved environments by creating a record of temperature against time. The great innovation of the chart recorder for temperature...

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The following nine attributes are common options for configuring a CMS. With each attribute, we offer methods and criteria for evaluating the fit between the system and your application. It's beyond the scope of this paper to address network connectivity, but we have addressed software that you are considering and make sure its UI meets your needs. A complex interface will frustrate users, negatively affect productivity, and may even become a source of errors. Some features of a well-designed UI include: extensive help section, intuitive functions like drag and drop, tab selection, and the...

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Look for alarm functions that provide flexibility in the alert and notification methods. Seek systems that are flexible to the personnel. For instance, some systems have alert options for e-mail, text, phone, flashing lights, and audible alerts. The system should have customizable options for who receives alarm, scheduling, acknowledgements, documentation and other configuration details. Define in advance what you need for reporting requirements and make sure your CMS can provide this. Start by analyzing your controlled the GxP requirements that apply to them. Because the guidances broadly,...

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Interoperable systems A CMS that is highly proprietary or supplied as a "black box" may create support issues, limiting your ability to change system configurations and locking you into service agreements. If you need to export CMS data to other systems, check Facilities with building automation choose to monitor through the BAS. Historically this has been preferable to using discrete devices for monitoring. However, today monitoring through a separate CMS will significantly reduce risks by providing features and attributes that are designed for the specific challenge of monitoring,...

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A continuous monitoring system from the right provider can offer value far beyond the cost of the system and services. It will mitigate risks, improve quality, meet regulatory requirements, reduce workloads and control costs. When a single catastrophic failure and product loss or adulteration is averted by a dependable system, it's clear that the total value of a CMS is more than the sum of its parts. However, system selection has to start somewhere; evaluating systems on the components most vital to its efficient and reliable function will provide crucial intelligence that will allow you...

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