In this technical presentation, the integration of customer-provided process and laboratory signals into GMP monitoring systems is discussed, as typically applied in pharmaceutical cleanroom environments. This includes both simple digital and analog signals as well as complex data interfaces, such as OPC UA or other IP-based communication protocols used to interconnect equipment, control systems, and data acquisition systems.

Not everything that is technically feasible is considered meaningful in this context; therefore, the intended purpose of the integration must be critically reviewed and evaluated. Does the integration serve solely for the archival of process data to make them available in conjunction with cleanroom monitoring data? Are process-dependent monitoring parameters to be triggered (e.g. switching of HVAC operating ranges), or is the complete monitoring of limit violations—including related notifications (signal lights, email alerts, connection to a control room, etc.)—to be transferred to and executed within the monitoring system?

Key aspects of any interface are secure data transmission in terms of reliability and fail-safe operation, as well as data security itself.

Technical feasibility does not automatically imply qualification suitability; therefore, the GMP risk must be assessed, as it forms the starting point for the qualification of such a system.