Managing the documentation maze: answers to questions you didn't even know to ask

This book provides no-nonsense, practical answers to questions about documentation and records management. It addresses the regulations and how they apply,and discusses sound documentation systems, electronic and hybrid. The authorsdefine, through a Q&A approach of more than 750 questions, what document management actually is, and why it needs to be a core discipline in the industry. Questions and responses also address how to select and validate an electronic system, system security, user accountability, and audit trails, as well as standard operating procedures that must be in place to support document systems.Janet Gough has extensive experience as a consultant to the pharmaceutical, biotech, and medical device industries. She designs systems for compliance withbinding regulations and conducts training accordingly. She assists companies in the preparation of documents including research and development reports, procedures, clinical documents, and regulatory filings. Ms. Gough is the author of 6 books (plus multiple editions of some of those). David Nettleton is a Compliance, Documentation, and Computer System Validation consultant involved with the development, purchase, installation, operation, project management, and maintenance of computerized systems used in regulated applications (GMP, GCP, GLP). He is author or co-author of 3 books.

• ISBN: 978-0-470-46708-4
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 474
• Fecha Publicación: 02/04/2010
• Nº Volúmenes: 1
• Idioma: Inglés