دانلود کتاب Testing Computers Systems for FDA/MHRA Compliance (Computer Systems Validation Life Cycle Activities)

Name: Testing Computers Systems for FDA/MHRA Compliance (Computer Systems Validation Life Cycle Activities)
Availability: InStock
Author: David Stokes
ISBN: 0849321638, 9780849321634

by David Stokes

عنوان فارسی: تست سیستم های رایانه ای برای FDA / MHRA پذیرش (سیستم های کامپیوتری اعتبار سنجی چرخه زندگی فعالیت ها)
ناشر: Informa Healthcare
سال: 2003
ویرایش: 1
زبان: انگلیسی
تعداد صفحه (نسخه چاپی - نسخه الکترونیکی): 136-118
شابک: 0849321638, 9780849321634
نوع فایل: PDF دانلود نرم افزار مطالعه
حجم: 7.00 مگابایت

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جزییات کتاب

Providing a thorough review of automated systems testing to meet the regulatory requirements of the FDA and MHRA, this book focuses on software module, software integration, hardware, and system acceptance testing. It covers current best practices in computer systems testing for the pharmaceutical and related healthcare manufacturing industries. Referencing content from the latest GAMP 4 guide, the author demonstrates how the principles detailed in GAMP 4 can be used to define a pragmatic approach to testing. The book includes techniques for testing large Internet-based systems for compliance with the stringent requirements of regulations such as 21CFR Part 11.

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