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Computer Software
PUBLISHED
- All(19)
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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 …
Hardback
$471.00
Containing four new chapters, along with several new and updated sections, this third edition reviews the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology. It presents the current …
PKCD
$299.95
This book explains how the formulas and procedures for sample size calculations can be used in a variety of clinical research and development stages. It presents real-world examples from several therapeutic areas and explores emerging topics in pharmaceutical research and development. This edition …
PKCD
$249.95
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 …
Paperback
$219.95
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 …
Hardback
$239.95
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 …
Hardback
$179.95
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 …
Hardback
$447.00
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 …
Hardback
$149.95
Completely revised and updated, this book is a practical guide for anyone involved in all levels of the development and quality assurance of software programs for healthcare products - particularly in the medical device and equipment manufacturing industries. From high-level strategies and …
Hardback
$239.95
This work provides not only guidance for generating documents but also templates that can be used to establish the documentation for a software quality assurance program for healthcare manufacturers. Readers can use the policies and guidelines as presented, modify them for use within their …
Hardback
$199.95
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