ABSTRACT
INTRODUCTION Validation is a subject that has grown in importance within the global healthcare industry over the past 25 years. During that time period, it has perhaps resulted in more changes in practices and methods, while causing more controversy than any other subject. Its relationship to facility design was not at all clear when it was first introduced in the early 1970s (1). It is now clear that validation and facility design are subjects that profoundly influence one another. One of the major concerns with any design-whether it be for a facility, a piece of equipment or a production process-is how its validation will be accomplished. Designers must now consider more carefully than ever before how their design will perform, as it must be “validated” prior to beneficial use. At the same time, validation programs must be established to facilitate the accomplishment of that very goal. A clear line of communication must be established to ensure that the operational objectives as implemented in the design can meet the validation requirements for that design. A well structured project team will mandate cooperation between designers and validators to meet the project’s dual goals of performance and compliance. This chapter reviews the aspects of validation as they impact the overall design, construction, and start-up of healthcare facilities.
