Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance
21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies
April 06, 2015
Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP...
Mariano Martín Martín
July 01, 2014
The field of chemical engineering is in constant evolution, and access to information technology is changing the way chemical engineering problems are addressed. Inspired by the need for a user-friendly chemical engineering text that demonstrates the real-world applicability of different computer...
February 23, 2010
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...
Istvan Majoros, James R. Baker, Jr.
May 31, 2008
In recent decades, dendrimers — free-shaped synthetic macromolecules — have garnered a great deal of scientific interest because of their unique molecular nanostructure. Used in a variety of scientific applications, dendrimers are now widely regarded as a safer, more precise and more effective way...
August 03, 2005
All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements...
January 15, 2004
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies...
December 18, 2003
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...
November 25, 2003
There is no substitute for extensive testing when it comes to IT systems. Recognition that problems are easier and cheaper to fix before the system is in use (rather than after), has turned testing into a cost-effective tool. However, when developing computer systems for pharmaceuticals...
May 31, 2000
One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP...
Joseph F. deSpautz
June 16, 1998
This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for...
Howard T. Garst Smith
June 30, 1997
Of all the audit functions faced by QA, software auditing is probably the most difficult because of the need to know and understand the intricacies of the processes being audited. In addition, auditors must be familiar with and understand the implications of the international and national standards...
Robert C. Jackson
July 23, 1996
It is estimated that 80 to 90% of drugs under development never make it to the marketplace due to insufficient clinical activity, unacceptable toxicity, rapid appearance of drug resistance, or other factors that should be, at least partially, predictable from preclinical testing. This new text asks...
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