EMS or BMS… what are they and

should they be separate?

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:

BMS (Good Engineering Practice) EMS (Good Manufacturing Practice)

Monitoring and historical logging of GMP critical environmental
parameters including:
Control of temperature, humidity and pressure
 Temperature
throughout a facility
 Pressure
 Particle Counts
Monitoring and historical logging of GMP critical equipment
including:
Control of plant (e.g. boilers, chillers, production or
 Fridges
waste water systems)
 Freezers
 Incubators
Provide access control security (e.g. card swipe Alarming of critical environmental and equipment out of
access) throughout a facility specification events
Strict access control including audit trail, electronic records and
Provide CCTV or video surveillance throughout a facility electronic signatures in line with FDA 21 CFR Part 11 and PIC/S
Annex 11

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:

Benefit of separate systems Details

Only EMS is the GMP critical system
Change management is only required for GMP
impacts
Monitoring data if the BMS stops
Quality of hardware
The BMS does not necessarily have to be fully validated because the
GMP critical data is logged and stored on the EMS. This simplifies
validation activities as EMS sensors will only be placed in GMP areas
(e.g. laboratories, critical storage, production suites, etc.) whereas the
BMS sensors are throughout the facility, including GMP and non-GMP
areas (e.g. offices, shared spaces, bathrooms, car parks, etc.).If the
systems are not separated, the BMS becomes the GMP system.
Obviously you don’t want to waste time validating sensors in a non-
GMP area just because they are attached to a GMP system.
If you wish to adjust a GMP critical set-point, it must be handled under
the facility Change Management system. If the BMS is the GMP
system, full change request documentation will need to be completed
even if, for example, Mary in Accounts wants the temperature turned
up a degree.
If the BMS was to stop, whether from failure or scheduled
maintenance, the EMS will continue to run and record regulatory data.
So the EMS could show that the product was maintained within the
specification even during a BMS outage.This could mean the
difference between saving or rejecting a batch.
Some BMS solutions are configured to use the BMS hardware,
software and sensors. Sometimes these sensors are of basic HVAC
quality and difficult to calibrate – that is, not what you would want for
a critical GMP system.Using higher quality sensors on the EMS can
achieve the accuracy and repeatability requirements needed.

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:
Type Size Pros Cons
 Can be difficult to manage
data
 Relatively inexpensive  Time consuming
< 20
Data Loggers  Wide range of loggers downloading data from loggers
points
 No wiring  Maintenance of batteries
 Alarm conditions not
obvious

 Ability to use mA or voltage inputs

meaning endless sensor possibilities  Limited number of input
Paperless Chart < 50
 Can auto backup to network server channels
Recorder points
 Can remote (via PC) view some  Installation costs
recorders

 Wide range of systems available

SCADA + PLC / > 50  Extremely flexible Client / Server  Expensive
DSC points architecture  Wired
 Easily implement redundancy