An Environmental Monitoring System (EMS) is very different from a Building Management System (BMS) – an EMS monitors the environment of a facility, whereas a BMS controls the environment.
What are the options?
There are many types and manufacturers of both BMS and EMS solutions, each with varying options. For example:
Are there different levels of compliance?
One of the main things to note with the installation of a BMS in a GxP environment is that its implementation typically falls under Good Engineering Practice (GEP) and not Good Manufacturing Practice (GMP). This means that the BMS has reduced documentation and validation requirements.
However, the installation of an EMS does fall under GMP, with all the expected validation rigor associated with GxP equipment and systems.
Should they be separate or combined?
As you can see, there is a clear difference between the intent of the two systems. However, a BMS and EMS are commonly combined into one system. A view is often taken along the lines of, “I’m already installing a BMS to control the environment, why can’t it monitor as well?”
However, there are many benefits to having separate systems:
What EMS system should I use?
There are many factors in choosing an EMS solution – but whatever system you choose, the system:
- Must be 21 CFR Part 11 and Annex 11 compliant
- Should be implemented in line with the GAMP5 guidelines.
Below are some different EMS solutions and the benefits and disadvantages of each system: