Environmental Monitoring Systems
Control and monitoring of storage and production environments are very important within the Pharmaceutical Industry. The FDA, MHRA, EMEA and other regulatory bodies require accurate measurement and storage of environmental parameters and, if the storage medium is electronic, the methods used must comply with FDA 21 CFR Part 11.
Over the last ten years however, there has been a shift to separate the BMS from the EMS as suggested by the ISPE. The immediate benefits include:
- Significant reduction in validation effort
- Changes made to the BMS do not affect the EMS
- Unscheduled stoppage of BMS does not affect EMS functionality
- Allows for independent parameter sensing if desired