Managing the Documentation Maze: Answers to Questions You Didn't Even Know to Ask

CHAPTER 8

NONCLINICAL RECORDS

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.

1. As a young company that has proof of concept for a new compound, at what point should we put document controls in place?
2. Why do so many products fail during development?
3. What controls should we think about first in the laboratory research setting?
4. What's the best way to manage our laboratory notebooks during research?
5. What's the best way to ensure that information goes into the notebooks correctly?
6. Is a notebook the property of the scientist or engineer to whom it is issued?
7. How do electronic notebooks work, and what are the advantages?
8. What do electronic notebooks require?
9. What ...