This document provides guidelines for auditing and evaluating validation documentation as part of a remediation project. It outlines key activities and items to evaluate for validation and qualification documents, including worst case scenarios, critical parameters and limits, and calibration. An example process validation list and equipment qualification list are provided. General guidelines are given for validation and qualification documentation stages and content. Qualification stages for equipment, facilities, and utilities are described, including installation, operational, and performance qualification. Types of process validation including traditional, continuous, and hybrid are briefly outlined. References for further information are listed at the end.