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

INTRODUCTION

If you didn't write it down, it didn't happen—that's the position of the FDA and other regulators. So what does that mean for companies? They need to keep records of everything they do. Good documentation is proof of product integrity; it's the confirmation of compliance; and it's just plain common sense. So how do they manage it all?

This book provides no-nonsense, practical answers to questions about documentation and records management. It addresses the regulations and how they apply, and it discusses sound documentation systems, electronic and hybrid. An entire chapter is devoted to making the transition to an electronic system, including how to validate and document the process. One chapter is dedicated to compliance, but many chapters will help you to understand regulatory issues and efficient compliance strategies.

Additional chapters address standard operating procedures, nonclinical records in laboratories and manufacturing, and clinical and regulatory documentation. A full chapter is dedicated to writing, reviewing, and approving documents so that they are consistent and readable.

Finally, this book offers advice on how to maintain a system once it is in place, and it tells how to keep it ready for scrutiny during any inspection. A final chapter provides additional resources for document management professionals.