Definition

Ongoing state of PV systems, documentation, and training such that an inspection can be supported at any time without last-minute preparation.

Example

Current SOPs, training matrix, and sample case files readily retrievable.

Regulatory source

GVP Module I, FDA CP 7348.001

Common mistakes

Preparing only when inspection is announced.

Inspector question

How do you maintain inspection readiness on a day-to-day basis?

Related terms