Testing Computers Systems for FDA/MHRA Compliance
David Stokes, "Testing Computers Systems for FDA/MHRA Compliance"
2003 | pages: 136 | ISBN: 0849321638 | PDF | 1,1 mb
2003 | pages: 136 | ISBN: 0849321638 | PDF | 1,1 mb
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.
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