Who will come to inspect? Young companies know that it is unlikely that the FDA or another regulator will come to inspect. Established companies know that they will, typically every two years or before a new product approval. But inspections are not always by regulators. Companies doing contractual research or manufacturing can be certain that inspections are forthcoming. And companies under consideration for purchase or partnering can expect to see inspectors at the door. During any inspection, for whatever purpose, quality plays a key role, and this means that documentation systems will be subject to scrutiny. This chapter addresses how companies can maintain inspection readiness, and it answers the following questions.