Testing Computers Systems for FDA/MCA Compliance |
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| David Stokes |
| November 2003, CRC Pr, Hardcover, 136 pages, ISBN 0849321638
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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/MCA 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.
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Author's Preface
1 Purpose 1
2 Scope 3
3 Why Do We Test? 5
4 What to Test 7
5 The Test Strategy 13
6 The Development Life Cycle of a Test Specification 27
7 Recommended Content for System Test Specification(s) 39
8 Good Testing Practices 55
9 Supplier System Test Reports/Qualification Reports 69
10 The Use of Electronic Test Management and Automated Test
Tools 71
App. A Hardware Test Specification and Testing 79
App. B Package Configuration Test Specifications and Testing
85
App. C Software Module Test Specifications and Testing 89
App. D Software Integration Test Specifications and Testing
91
App. E System Acceptance Test Specifications and Testing 93
App. F Risk-Based Testing 95
App. G Traceability Matrices 99
App. H Test Script Templates 105
App. I: Checklists 113
App. J: References and Acknowledgments 119
Index 121 |
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Booknews, Inc
Reflecting the renewed emphasis of the FDA and other global regulatory
agencies towards systematic inspections and risk-based validation,
this guide focuses on current best practices in computer systems
testing in the regulatory environment, specifically the pharmaceutical
and related healthcare manufacturing industries. The book references
content from the latest GAMP 4 Guide [1] and shows how the principles
detailed in GAMP 4 can be used to define a pragmatic approach to
testing. Author information is not given. Senior managers, project
team leaders, and industry trainees will benefit from the guide.
Annotation ©2004 Book News, Inc., Portland, OR
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