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

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

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

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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Safeware: System Safety and Computers

Safeware: System Safety and Computers Review

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Safeware: System Safety and Computers Feature

We are building systems today-and using computers to control them-that have the potential for large-scale destruction of life and environment. More than ever, software engineers and system developers, as well as their managers, must understand the issues and develop the skills needed to anticipate and prevent accidents. Nancy Leveson examines what is currently known about building safe electromechanical systems and looks at past accidents to see what practical lessons can be applied to new computer-controlled systems.

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