In the pharmaceutical industry regulations, you will find a requirement for environmental monitoring system (EMS). It is a GMP requirement. That is what will give the quality assurance that you were in control when you manufactured your product.
If you need the temperature of your room to stay between a certain range, the EMS will continuously record the temperature. It will then send you an alarm notification if the temperature goes below or above the thresholds you set up. You can configure those alarms based on your process needs and for any critical parameters you must control. Those critical parameters will be recorded and entered into the composition of your batch record (EBR). This will demonstrate that during manufacturing, you were within your state of control.
The usual critical parameters an EMS monitors are temperature, relative humidity, pressure, particle counting but is certainly not limited to these.
An EMS monitors the environment. In a pharmaceutical facility, your system must be qualified, and all data must be stored to show historical compliance to production requirement. To be compliant with FDA 21CFR Part11, an EMS must have the following features: audit trail, electronic record and electronic signature. An EMS in the pharmaceutical industry falls under Good Manufacturing practice (GMP).
