This category addresses the automation and monitoring functions used to support facility and HVAC system performance in GMP-regulated environments. It focuses on how environmental parameters are monitored, controlled, alarmed, and maintained to sustain a state of control. Topics include system architecture and concepts, environmental monitoring of controlled areas, alarm management practices, qualification and verification of automation functions, and lifecycle activities such as change control and periodic review.
Purpose and Scope Facility automation and monitoring systems maintain, observe, alarm, record, and communicate conditions within GMP facilities. These functions may be distributed among: System names alone do not establish GMP significance. A system called a BMS may control HVAC…
Purpose and Scope Facility automation architecture defines how sensors, controllers, supervisory systems, networks, data repositories, alarm services, and supporting infrastructure work together to control and document GMP facility conditions. Architecture must establish more than a list of installed components. It…
Purpose and Scope Qualification and verification of facility automation systems establish documented evidence that computerized control, monitoring, alarming, recording, and reporting functions are suitable for their intended GMP use. The scope may include: Facility automation should not be treated only…
Purpose and Scope Change control and periodic review maintain facility automation systems in a qualified and controlled state after initial release. The scope may include: The lifecycle process should address changes to hardware, software, firmware, configuration, records, infrastructure, security, operating…