ABSTRACT
INTRODUCTION The various compliance approaches promoted within the pharmaceutical and healthcare industry by GxP regulators, industry initiatives, and individual pharmaceutical and healthcare companies all adopt the same basic approach. This follows the following basic steps:
l Define what is to be done (plan) l Define how to do it (specification, procedures, and resources) l Do it, controlling any changes (change control) l Establish that the end result was what was originally intended (verification) l Provide evidence demonstrating this (audit trail)
This chapter presents the set of life cycle phases summarizing the project approach typically adopted within the pharmaceutical and healthcare industry. These life cycle phases may be known by alternative names within different organizations, as there are yet no generally accepted naming conventions or groupings of phases throughout the industry. It is important, however, that all the activities covered by this chapter are included in any alternative scheme.
