Which System is Right for You?

Freezers, Incubators, fume hoods, humidity, temperature, light intensity, pressure, gasses... There are a lot of critical equipment and ambient environmental conditions that need to be monitored in a lab to ensure scientific reproducibility and quality. In this white paper we'll discuss the differences between a Building Management System (BMS) and Environmental Monitoring System (EMS), and why only using the former as the latter can cause several complications such as data integrity risks, lack of compliance, and minimal sensor data.

A Building Management System (BMS), also referred to as a Building Automation System (BAS), is used to control and monitor facilities’ systems like heating, cooling, and ventilation, but also lighting, power, fire, and security systems. While a BMS focuses primarily on the real-time control aspect, one very key differentiator is that the sole purpose of an Environmental Monitoring System (EMS) is to very accurately monitor equipment and environmental conditions within the facility in real-time, and provide actionable insights through reporting and alarms. The EMS data is an invaluable tool for example to get a drug to market faster, prove compliance, and increase research reproducibility by removing variables. It’s a scientific tool built for scientific purposes - which a BMS is not.

The BMS is primarily used by facilities teams while an EMS is critical for laboratory staff and quality departments. An EMS adds additional insight and more importantly: granularityto what’s going on in your facility by very accurately and independently monitoring conditions, such as temperature, humidity, CO2, and air quality. They canalso measure data from critical equipment such as fridges, freezers, bioreactors,and incubators.

In industries such as manufacturing, pharmaceuticals, and other GxP-regulated environments, facilities require both Control (BMS) and Monitoring (EMS) solutions as they’re both essential in reducing external variables that can be detrimental to scientific work. Since Good Manufacturing Practices (GMP) are based on regulatory compliance and validation, an EMS is not just helpful, but required, to adhere to strict regulations.

Using a BMS as your EMS

While many facilities decide to use their BMS for monitoring purposes, a BMS ultimately serves a different purpose and limits monitoring capabilities for equipment and conditions. Stretching the use of your BMS past its objective to control leads to issues such as minimal sensor data, no independent calibrated sensors, data integrity risks, and lack of documentation proving compliance. We'll dive into each of these issues in more detail below.

Minimal Sensor Data

A BMS will often utilize a dry contact alarm (a simple alarm intended to tell you whether a parameter is outside of regular operation, but no more). A dry contact will alert you when a piece of equipment is alarming, but not why. These simple alarms create issues in understanding what’s happening in your facility and proving compliance in the event of an audit. Experience shows that the reliability of these dry contacts is far from perfect: if the unit fails, often no alarm goes out - or if the inside sensor is wrong, the dry contact will not know any difference. Using your BMS to monitor all environmental conditions within your facility and equipment leads to a lack of data and no “paper trail” for quality purposes. A BMS is designed to handle a wide range of applications, but capturing scientifically relevant data in an auditable, 21 CFR Part 11 compliant format is not one of them. Sensors often vary greatly in terms of quality and bad data means more concerns for operations and QC in the long run.

Sensors

When the control aspect of your system also happens to be your monitoring solution, issues in your sensors may begin to arise. What a QA department views as ample system maintenance and calibration regimens don't always line up with what Facilities need or can accommodate on the BMS. With high-quality independent calibrated sensors from your EMS, you gain another layer of redundancy and accuracy to make certain your data is reliable. Implementing an EMS in addition to your BMS will better safeguard your environment and equipment to ensure that no unforeseen mishaps arise. Auditors (internal or external) and QA/ QC departments often look for very accurate, finite datasets to ensure all correct procedures have been followed; this is where an EMS shines.

Access to Data

Within Life Science organizations, there are varying teams working together such as facilities, lab operations, and quality departments, and they all need different sets of data. If a BMS is the only system used, gaps are left between these departments in terms of reporting and standardization, especially for the Quality team when it comes time for an audit and proving compliance. With just a BMS, it’s difficult to track a comprehensive log of individual user actions, excursion reviews, or who is acknowledging alarms. It will also make it difficult to assign alarms to different users (or very limited user-level control compared to an EMS). For instance, you may be relying very heavily on your facilities department for responding to alarms with no way of tracking them. Per CAP guidelines, lab staff must be notified of alarms, so depending on regulatory needs a BMS may immediately set you up for failure. An EMS system enables you to segment your data based on various user roles, types of equipment, locations within a building, or even lab space itself. This level of granularity is imperative to manage complex settings, and ensure the process from storage to research, production, and shipping is combined in 1 system.

Impact on Compliance

For many life science companies, an EMS isn’t only helpful; it’s required. All of the issues above lead to a lack of documentation proving compliance, research reproducibility issues, difficulty with system validation, and a disconnect of end-users getting access to the information they need. Due to those issues, it is incredibly difficult to validate the system. Even initial validations of a BMS will create huge headaches for quality and operations down the road as every little change needs to be meticulously documented or risk not having data needed for an audit. EMS systems are designed for compliance, QA, audits, and alike. Most often, they will come with the appropriate IQ/ OQ (Installation Qualification/ Operational Qualification) documentation, built-in compliance reports, and will have simple interfaces to gain access to compliance data.

Benefits of an EMS in addition to a BMS

Using an EMS in addition to a BMS offers many benefits; for instance, an EMS provides an independent built-to-purpose system that includes its own validated data if the BMS stops, and hardware (sensor) flexibility. In the event of total failure, an EMS is designed for remote access and visibility of critical systems and equipment with its own battery backup/ failover system and data buffering. It will provide data that scientists care about in those instances, where a BMS will focus more on getting power and network reestablished. Again, a BMS focuses on the whole, not the detail, while an EMS is designed to work and provide per-sensor visibility in situations when a BMS typically would not. It has the capacity to integrate with independent battery backups, connectivity failover (4G), as well as local audible and visual alarms (such as ambient O2 alarms). Without these failovers, your facility is susceptible to safety and compliance risks.

Read more about Facility Monitoring in our eBook: The Ultimate Guide to Life Science Facility Monitoring

Validation

Having a separate EMS in place ensures that all sensors are independent and the data generated holds your BMS accountable. The main difference between the two for validation is that an EMS is designed to be validated and create audit trails. A BMS is designed to control systems and adjust accordingly. Validating a BMS is a continuous and error-prone task for quality and operations teams. One potential solution is to implement a BMS and split the data from EMS sensors into BMS wherever applicable. This makes it easier to maintain each system separately and the BMS benefits from the accuracy of the EMS sensors. Yet this creates a different set of validation challenges.

The preferred method is to identify which sensor points are critical for each system and to split the data from EMS sensors into the BMS where applicable. This makes it easier to maintain each system separately and the BMS benefits from the accuracy of the EMS sensors.

GxP Compliance

For GxP-regulated environments, they are under heavy scrutiny from the FDA and other regulatory bodies to prove a state of control and a methodical way of reducing variation in their processes. All EMS data must be GxP compliant, so records must include certain timestamps and be able to prove that the product was manufactured in the correctconditions. Another aspect needed to adhere to GxP guidelines is FDA 21 CFR Part 11 compliance. Many BMS systems have not been designed to adhere to 21 CFR Part 11, and as such, may lead to red flags during audits. But the larger part of validation is the ongoing Performance Qualification. If a BMS is validated, any issues that an auditor may find will require additional safeguards put into place with more rigorous testing to ensure results are repeatable. With so many interconnected parts of a BMS, and the primary purpose being to control systems, ongoing PQ can create a huge ripple effect ultimately drowning the QA department in paperwork.

Backup Data

If your BMS were to experience technical issues and the system went down, the BMS would stop taking data points until the problem was resolved. This is why two systems are necessary and where an EMS would save the day. Say, for instance, if a piece of equipment, such as a freezer or refrigerator, was to go outside the normal temperature parameters during the BMS’ technical failure, your EMS would alert of the abnormality and record the data. Without that data, you do not know what to do with any potentially compromised product, reagents, samples, etc. In most instances, the items would have to be tossed out since you cannot prove the materials did not experience a very impactful excursion. As a separate system, the EMS wouldn’t be impacted by the BMS’ downtime and would continue to monitor your most critical equipment and environmental conditions to provide actionable data. This level of redundancy is critical for temperature - and time-sensitive assets. Adopting an EMS, and more particularly, one with multiple safeguards such as a backup power supply and a 24/7 support team will ensure that your science will be protected.

Flexibility of Hardware

While a BMS is rigid with many costly customizations required to add new units and parameters, an EMS will be flexible. For a BMS, critical things like data drops, power sources, gas lines, and other utility systems are built into the building and are not easily moved. Additional items like these can be dropped into new areas, but it can be very costly to do so. An EMS just needs to leverage things like power sources and data drops to become much more flexible in the actual space and monitor many more parameters. An EMS is designed to leverage the critical utilities provided by the BMS to specific locations as you continue to expand.

BMS and EMS: an Overview

While a BMS focuses primarily on the real-time control aspect, the purpose of an EMS is to monitor equipment and environmental conditions and provide actionable insights through reporting and alarms.

In industries such as manufacturing, pharmaceuticals, and other GxP-regulated environments, facilities require both Control (BMS) and Monitoring (EMS) solutions as they’re essential in reducing external variables that can be detrimental to scientific work. While both are necessary, they each have their own responsibilities.

This is a quick overview, where everything is unique to everyone’s own building and situation. This is why it’s so important to work with monitoring partners who are experts in the space.

Summary

There are many pieces of critical equipment, building systems, and environmental conditions that need to be monitored in a lab to ensure scientific reproducibility and quality. Stretching the use of a BMS beyond its primary purpose of control will cause several complications such as minimal sensor data, difficulties with validation, and no auditable “paper trail” for quality purposes.

While a BMS focuses primarily on the control of building systems, an EMS is used to monitor equipment and environmental conditions within the facility. The EMS data is an invaluable tool to get a drug to market faster, prove compliance, and increase research reproducibility by removing variables.

In larger facilities and labs, there are many teams working together, such as facilities, lab operations, and quality departments. If you’re only using a BMS, there is a disconnect among departments, especially for the Quality team when it comes time for an audit and to prove compliance. Since GxP is based on regulatory compliance and validation, an EMS is helpful, and usually required, to adhere to strict regulations.

In the life sciences industry, facilities require both BMS and EMS solutions as they’re both essential in reducing external variables that can be detrimental to scientific work. The ideal outcome is to implement a BMS and split the data from EMS sensors into your BMS when applicable. This makes it easier to maintain each system separately and the BMS benefits from the accuracy of the independent EMS sensors.

There are many factors to consider when evaluating different environmental monitoring solutions, and there’s no one-size-fits-all solution. This is why you should partner with an EMS provider that offers monitoring-as-a-service that is tailored to every client’s specific business goals and needs. A service-based approach allows for the safest protection of samples, seamless data integration with your BMS, and future scalability as your lab continues to grow. Schedule a free consultation with one of our experts now:

To learn more about how XiltriX can ensure your facility’s critical assets and equipment are protected 24/7/365, schedule a free consultation with one of our experts.