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Focusing on automated systems testing, this book provides a comprehensive review tailored to FDA and MHRA regulatory standards. It addresses software module, integration, hardware, and system acceptance testing, emphasizing best practices in the pharmaceutical and healthcare sectors. Drawing from the latest GAMP 4 guide, the author outlines a pragmatic approach to testing and includes techniques for ensuring compliance with stringent regulations like 21CFR Part 11, particularly for large Internet-based systems.
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Testing Computers Systems for FDA/MHRA Compliance, David Stokes
- Jazyk
- Rok vydania
- 2003
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- Titul
- Testing Computers Systems for FDA/MHRA Compliance
- Jazyk
- anglicky
- Autori
- David Stokes
- Vydavateľ
- CRC Press
- Rok vydania
- 2003
- Väzba
- pevná
- Počet strán
- 136
- ISBN13
- 9780849321634
- Kategórie
- Biológia
- Anotácia
- Focusing on automated systems testing, this book provides a comprehensive review tailored to FDA and MHRA regulatory standards. It addresses software module, integration, hardware, and system acceptance testing, emphasizing best practices in the pharmaceutical and healthcare sectors. Drawing from the latest GAMP 4 guide, the author outlines a pragmatic approach to testing and includes techniques for ensuring compliance with stringent regulations like 21CFR Part 11, particularly for large Internet-based systems.