A well-understood tenet exists among the FDA and other regulatory bodies: if it isn't written down, it didn't happen! And if it didn't happen, companies stand to lose time, money, and perhaps their 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 to QA to manufacturing and regulatory affairs. The book offers valuable insights into managing systems and producing documentation that meets the requirements of both the FDA and ISO 9000.
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Write It Down: Guidance for Preparing Documentation That Meets Regulatory Requirements
By Janet Gough
Published by CRC Press, 1999
ISBN 1574910884, 9781574910889
350 pages