Description

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

More Details about Pharmaceutical Computer Systems Validation Quality Assurance Risk Management and Regulatory Compliance 2e (HB)

General Information  
Author(s)Wingate
PublisherInforma Healthcare
Edition2
ISBN9781420088946
Pages765
BindingHard Back
LanguageEnglish
Publish YearJanuary 2010