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Why Your Environmental Monitoring System is Failing

A healthy EMS requires reliable infrastructure, high-quality hardware, and comprehensive staff training

by
Michael Cross

Michael Cross leads the business development team at XiltriX North America. Working with numerous GxP, FDA, CAP, and CLIA regulated laboratories, Michael has extensive experience working with biotech and pharmaceutical...

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Has your environmental monitoring vendor sold you a fairy tale and now you’re living in a nightmare? Laboratories rely heavily on environmental monitoring systems (EMS) for support and to safeguard their research, assets, and data. However, if you’re not working with the right provider, it can compromise your lab’s effectiveness and intellectual property, giving you the illusion that things are running smoothly. 

Unreliable connection and infrastructure

When it comes to laboratory monitoring, uninterrupted connection is essential to ensure facility health. Relying on wireless networks, Wi-Fi, or Bluetooth introduces vulnerabilities and insufficient safeguarding that threatens the integrity of your science. In most cases, a loss of connection can result in a loss of data. 

Additionally, the rapid evolution of Wi-Fi protocols can affect hardware’s longevity. Costly upgrades can lead to a mixture of incompatible hardware, firmware, and software, stretching budgets and patience. If your EMS leverages a mesh network, the sensor’s endless search for the strongest signal strains battery life and reduces the sensor’s lifespan.

With that being said, these issues can contribute to your staff experiencing alarm fatigue, a symptom of unreliable infrastructure. If connectivity drops and reconnects, a flurry of alarms is created and overwhelms users trying to determine if any of the alarms are real—that’s when alarm fatigue fully sets in.

Data loggers face their own challenges on top of alarm fatigue. They collect data at set intervals and upload it to the cloud at set intervals, but there’s no information gathered or uploaded between points. For reference, systems where sensors are powered by batteries are considered data loggers. Increasing the frequency at which data is captured and uploaded causes batteries to die faster. When it comes to system installation and hardware quality, data loggers tend to fall short in areas far beyond just battery life. 

...Though a plug-and-play system may seem easy, it typically is not suited for a high-functioning scientific environment.

Given these considerations, though a plug-and-play system may seem easy, it typically is not suited for a high-functioning scientific environment. The choice between plug-and-play and professional installation can significantly affect system performance, jeopardizing research integrity and generating excess maintenance costs. Furthermore, having employees install the system takes them away from their value-added tasks. Having a vendor do the installation holds them responsible and adds a layer of certainty since they can rectify issues promptly. 

Poor connection and unreliable infrastructure in the lab can give you a false sense of security that everything is working, leaving you unaware that the data is buffering or stopped. It also reinforces bad habits such as employees ignoring alarms, which can lead to equipment failures and substantial financial losses. Unreliable connection and hardware quality shouldn’t be underestimated, but labs commonly opt for “budget-friendly” units that end up costing them more in the long run. 

Lack of support and training

Are you getting enough support and training? Is it included in your offering? Ignoring these factors due to cost leaves employees unequipped to manage the system effectively, especially when they need a refresh. Long support queues and the inability to get technicians onsite, combined with the absence of ongoing training, can have a significant negative impact on lab operations. 

Proper administration and configuration are essential for user adoption, but they’re often overlooked, which leads to a loss of trust in the system. Moreover, the departure of a user can result in the loss of tribal knowledge, creating learning curves and potential missteps.

In the realm of regulatory compliance, such as transitioning to GxP, the absence of proper support can have negative consequences on validation, audit support, and reporting assistance. For example, does your vendor provide a well-vetted Installation Qualifications or Operational Qualification (IQ/OQ) Packet? Other key questions to ask:

  • Who does the documentation for IQ/OQ? 
  • What ongoing support is offered? 
  • Do they help with Performance Qualification (PQ)?

The importance of reporting cannot be overstated, but it’s an intricate process. Users often struggle to retrieve data across various systems, resulting in complicated auditing, administrative costs, and underutilized data. Another issue lies in customization. When options are limited, it hinders the ability to generate tailored reports featuring graphs, statistics, numerical data, or multiple sensor parameters on a single graph. 

What should you expect, then? In the ideal scenario, end users should have a system with all relevant data in one location (facility systems, environmental conditions, and equipment functionality). They should receive help from a support team with customizing and automating reporting. The team should also be available to provide refresher training and help generate specific information needed for audits. 

Proper administration and configuration are essential for user adoption...

It’s important to consider that needs will change over time as you transition into the GxP space, so you need to ensure that you have a reliable partner who can help your team tackle new challenges as they arise.

Costly upgrades

Just as reporting can drive up operational costs, upgrades, varying software versions, and licensing costs can cause additional financial challenges. Technology is continually becoming obsolete, and that comes with the need for replacement. Ensuring compatibility among systems is essential, and this shouldn’t require you to be an expert in the vendor’s technology for it to function seamlessly. You shouldn’t have to worry about whether the replacement part works; the vendor should always take care of that so you can focus on your work.

It’s worth mentioning that straightforward additions can come with unexpected costs, like needing more gateways to support more sensors or needing additional licenses. Part replacement is also costly, and the turnaround time might place your company at risk. 

To sum up, your vendor should offer top-tier service, provide quick responses, and handle the system’s complicated aspects. This will allow your team to utilize the data to make informed decisions and remain focused on what they do best. Furthermore, the ideal EMS will prioritize real-time monitoring, favoring a wired solution for uninterrupted data integrity that doesn’t rely on batteries. If any of the above scenarios hit close to home, it might be time to start looking for a new vendor.