Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
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  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
Testing Computers Systems for FDA/MHRA Compliance

Testing Computers Systems for FDA/MHRA Compliance

Stokes, David

Hardcover

Series: Computer Systems Validation Life Cycle Activities S

Medical ReferenceTechnology & EngineeringOperating Systems

ISBN10: 0849321638
ISBN13: 9780849321634
Publisher: CRC Press
Published: Nov 25 2003
Pages: 136
Weight: 0.88
Height: 0.53 Width: 7.46 Depth: 9.76
Language: English
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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