Nonclinical documentation has a wide scope. What you must manage depends in total on where you are in the life cycle of a therapeutic product. If you are just beginning to develop a product and have proof of concept, you may be ready to move into Good Laboratory Practices (GLPs) to test for safety in the animal model. GLP regulations are clear in what you must do. If you are further along in development, you are amassing documentation that supports proof of concept for testing in humans. If you have product in the marketplace, you must maintain manufacturing and distribution records and track products in the market, including handling complaints and managing field alerts and recalls. This chapter provides answers to these frequently asked questions about document controls.