Testing Computers Systems for FDA/MHRA Compliance (Computer Systems Validation Life Cycle Activities S)
$180.00
Description
Book Synopsis: 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 manufacturing, testing to meet regulatory requirements adds an additional layer of complexity. Testing Computers Systems for FDA/MHRA Compliance focuses on software module, software integration, hardware, and system acceptance testing. Reflecting the renewed emphasis of the FDA and other global regulatory agencies towards systematic inspections and risk-based validation with an underlying scientific rationale, this guide focuses on current best practices in computer systems testing in the regulatory environment. David Stokes demonstrates how the principles detailed in the GAMP 4 Guide can be used to define a pragmatic approach to testing. He includes techniques for testing large Internet-based systems for compliance with the stringent requirements of regulations such as 21CFR Part 11, and clarifies the relationship and responsibilities of the system "user" and "supplier". The author also delineates where testing starts in the project lifecycle, who performs what testing, where the lines of responsibility start and end, and the differences in the terminology used in the healthcare and general IT sectors. A checklist of questions to be used when developing System Test Specification(s), and templates for documenting typical system test results, round out the features that make this book a practical guide for all those involved in the development and implementation of IT systems for the pharmaceutical and related healthcare manufacturing industries. Senior managers, team project leaders, project team members, and industry trainees, will all benefit from this clear and practical guide.
Details
Are you developing computer systems for pharmaceuticals manufacturing? Don't overlook the crucial step of testing for FDA/MHRA compliance. Testing Computers Systems for FDA/MHRA Compliance is your comprehensive guide to navigating the complex world of regulatory requirements. With the renewed emphasis on systematic inspections and risk-based validation, this book focuses on current best practices in computer systems testing in the regulatory environment. Let David Stokes guide you through the principles detailed in the GAMP 4 Guide and show you how to define a pragmatic approach to testing. From software module and hardware testing to system acceptance testing, this book covers it all. Don't risk regulatory non-compliance, get your copy today and ensure your systems are up to standard.
In the pharmaceutical and healthcare manufacturing industries, testing is essential for ensuring the safety and effectiveness of computer systems. Testing Computers Systems for FDA/MHRA Compliance provides you with the knowledge and techniques needed to meet regulatory requirements. With a focus on compliance with regulations such as 21CFR Part 11, this book demonstrates how to test large internet-based systems and clarifies the responsibilities of both the system "user" and "supplier". From defining a pragmatic approach to testing to documenting system test results, this book covers it all. Whether you are a senior manager, project leader, or industry trainee, this practical guide will be an invaluable resource for your IT system development and implementation efforts.
Don't let the complexity of regulatory requirements deter you from testing your computer systems. Testing Computers Systems for FDA/MHRA Compliance breaks down the testing process into manageable steps and provides you with the tools you need for success. With a focus on current best practices and a practical approach, David Stokes guides you through the testing process, ensuring that your systems meet the stringent requirements of regulatory agencies. From software integration to system acceptance testing, this book covers all aspects of computer systems testing in the regulatory environment. Get your copy today and ensure that your systems are compliant with FDA and MHRA regulations.
Ready to take the necessary steps to ensure regulatory compliance in your computer systems? Testing Computers Systems for FDA/MHRA Compliance is the guide you need to navigate the complex world of testing in the pharmaceutical and healthcare manufacturing industries. With a focus on current best practices and practical techniques, this book provides you with the knowledge and tools you need to succeed. Don't risk regulatory non-compliance, get your copy today and start testing with confidence.
Ready to take the necessary steps to ensure regulatory compliance in your computer systems? Testing Computers Systems for FDA/MHRA Compliance is the guide you need to navigate the complex world of testing in the pharmaceutical and healthcare manufacturing industries. With a focus on current best practices and practical techniques, this book provides you with the knowledge and tools you need to succeed. Don't risk regulatory non-compliance, get your copy today and start testing with confidence. Click here to purchase now.
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