Write It Down: Guidance for Preparing Documentation that Meets Regulatory Requirements

by Janet Gough

A well-understood tenet exists among the FDA and other regulatory bodies: if you didn't write it down, it didn't happen! And if it didn't happen, your company stands to lose time, money, and perhaps its competitive edge. This book provides writers with the tools they need to put effective documentation in place. It offers a broad range of documents representative of the types of writing in the healthcare industry, from the laboratory and QA to manufacturing and regulatory affairs. The book offers valuable insights into managing systems and producing documentation that meets the requirements of the binding regulations.

368 pages, Hardcover

First published October 1, 1999