ABSTRACT
Validation has become ingrained in the healthcare
industry since the mid 1970s, when it was first intro-
duced. Over the years the nature and scope of validation
has changed as it has been applied in a variety of
situations. Given its maturity, it might seem possible
that future changes in its application would be minimal.
This chapter endeavors to explore future shifts in the
industry and how validation might be impacted by those
changes. The primary drivers for change in industry are:
further advances in technology; a rapidly shifting regulat-
ory environment; and the ever-present commercial
concerns of business.
