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You are here > Home > Reading Lists > Information Systems, Medical Records  & Technology Books > Computer Systems Validation

Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Health Care Companies
Guy Wingate

Hardcover: 1,032 pages
ISBN 0849318718
CRC Press
December 2003
Price: $499.95

 

Computer Systems Validation is 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 FDA and other regulatory authorities. 

Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality assured, and validated. 

The most comprehensive guide on computer validation currently available, containing more than 200 illustrations and more than 100 tables, Computer Systems Validation helps you see the big picture.

The author reviews regulations and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement. He presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. 

Covering methods that help you avoid duplicating effort among departments and business functions, the book demonstrates how you can use your investment in technology to improve business efficiency and gain the competitive edge.

Practical examples and checklists appear throughout the book, together with an exploration of the role of quality assurance and risk management as key components of pragmatic regulatory compliance. 

  • Contains 24 case studies illustrating the practicalities of validating different types of computer systems supporting laboratories
  • Discusses GCPs, GLPs, GMPs, GDPs, and Medical Device regulations from around the world, with explanations of the latest regulatory developments from the US FDA
  • Supplies comprehensive coverage of computer validation principles and how to put them into practice
  • Contains more than 200 illustrations
  • Includes more than 100 tables
  • Presents practical examples and checklists throughout

This resource also reviews over twenty case studies from renowned industry experts who examine different types of computer systems.

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