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.
Key topics in Pharmaceutical Computer Systems Validation, Second Edition include:
|Title:||Pharmaceutical Computer Systems Validation: Quality, Assurance, Risk Management and Regulatory Compliance||Publisher:||Informa Healthcare|
|No. of Pages:||765|
* The book summary and image may be of a different edition or binding of the same title.
* Book reviews are added by registered customers. They need not necessarily buy book.
* These books are NOT available for reading online or for free download in PDF or ebook format.
* Price can change due to reprinting, price change by publisher or sourcing cost change for imported books.
www.infibeam.com/Books is the biggest online bookstore in India for sale of books at best price - fiction, literature, audiobooks, study guides, novels, story books, rare books, textbooks and books by popular authors. These are available in various editions and bindings e.g. paperback and at best discount.