Computer Systems Validation: Quality Assurance, Risk...

Features

• Cover Type: Hard Cover with 1032 pages
• Published by: Informa Healthcare
• Edition: 1st Edition December 18, 2003
• Written in: English
• ISBN 10 Number: 0849318718
• ISBN 13 Number: 978-0849318719
• Book Dimensions: 10.1 x 7.2 x 2.5 inches
• Weighs: 4.2 pounds

Product Review
…Whether you are looking for the missing piece of the jigsaw puzzle for your project or guidance on how to meet the regulations in a practical sense, this information resource (which puts principles into practice) is a good place to start!
- from the foreword by Anthony Trill, Medicines and Healthcare Products Regulatory Agency (MHRA)

Book Description


The most comprehensive guide to computer validation currently available, this invaluable reference discusses good laboratory, clinical, manufacturing, and distribution practices and explains the latest regulatory developments for the US, European and other regulatory authorities. Practical examples and checklists appear throughout the book and the authors explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. He reviews over twenty case studies of different types of computer systems. Latest FDA and PIC/S developments concerning computer validation, electronic records and signatures, and process analytical technologies are included.