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Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory ComplianceFrom CRC Press
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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:
- GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008
- ICH Guidance Q8, Q9, and Q10 expectations
- FDA cGMPs for the 21st Century Initiative and associated guidance
- PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments
- WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
- the indirect developments from FDA/EU/Japan regulators and industry
- the role of QA department, and internal and external suppliers
- the integration of computer systems validation into single overall approach for wider system
- practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system
- managing outsource partners and handling legacy systems
- topical issues uncovered by regulatory authorities including US FDA
- Sales Rank: #1929395 in Books
- Published on: 2010-02-23
- Original language: English
- Number of items: 1
- Dimensions: 10.30" h x 1.90" w x 7.30" l, 4.15 pounds
- Binding: Hardcover
- 798 pages
Most helpful customer reviews
3 of 3 people found the following review helpful.
Excellent reference for Computer Validation
By Armand Mintanciyan
If you are thinking about a career move into computer validation or are already involved in computer validation this book makes a tremendous reference. I feel this book and the 'GAMP5 Guide: A Risk Based Approach to Compliant GxP Computerized Systems' will be of great value. I have been involved in computer validation since 1994 including lead roles in Consent Decree remediation for computerized systems and I highly recommend this book.
0 of 0 people found the following review helpful.
Validation
By Arlyn R. Sibille
For the serious minded the book has the detail required to understand how to approach the validation of pharmaceutical computer system for laboratory equipment. Based on the Risk Approach.
0 of 0 people found the following review helpful.
This is a useful companion to GAMP 5
By Jeff M. Lewis
This is a useful companion to GAMP 5, and much less expensive. The book is well organized and discusses validation scenarios for a number of different system types.
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