Through Food and Drug Administration (FDA) opinions and rulings, compliance policy guides, published articles, and industry associations, the validation of process control systems is becoming more standardised. More formative is the methodology used to validate the building control and monitoring systems often supplied as direct digital control (DDC) on projects that require adherence to current good manufacturing practices (CGMPs). There are many questions as to the depth of activity needed to validate systems that, in their most benign form, exist as `background' to the product, but that, in their most impactive form, can have a direct influence on research or product quality. This paper attempts to place perspective on the emerging requirement to validate DDC systems and to do so by focusing on the clinical supply laboratory.

KEYWORDS: laboratories, pharmaceuticals industry, building services, construction, designing, validating, monitoring, controls, computer controls, standardisation.