Facility Monitoring Systems Validation: A Practical Approach 1

By Mike Gough

While most professionals working in the pharmaceutical industry have thorough understanding of process validation, the validation of computer systems in process applications is less widely understood.
The problem is, of course, that microprocessors are now built into equipment throughout the pharmaceutical facility. They’re in formulation, stock control, integrated manufacturing, environmental monitoring, laboratory analysis, vision inspection systems, and even in chart recorders and temperature controllers. To ensure process integrity, each one of these devices must be properly calibrated as part of the larger validation process.
Simply having an understanding of computers and software systems isn’t enough: it’s not only essential to fully understand the process, but the equipment being validated as well. This can be difficult because those who best understand the equipment are the manufacturers, but often they may know little or nothing about validation.
This article addresses only one critical aspect of computer-based systems validation: the validation of Facility Monitoring Systems (FMS).
FMSs are normally used only for cleanrooms and associated areas. Such systems cannot be used to classify an area or facility; they perform a monitoring function only, providing evidence that the environmental conditions in the monitored area have been maintained within specified limits. FDA and other regulatory bodies do accept, however, that for users of an FMS, the period of reclassification can be extended (see ISO 14644-2).