David Stokes

Testing Computers Systems for Fda/Mhra Compliance

• Gebundenes Buch

Produktbeschreibung

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.

Produktdetails

• Verlag: CRC Press
• Seitenzahl: 136
• Erscheinungstermin: 25. November 2003
• Englisch
• Abmessung: 248mm x 189mm x 13mm
• Gewicht: 399g
• ISBN-13: 9780849321634
• ISBN-10: 0849321638
• Artikelnr.: 21783533

Autorenporträt

David Stokes

Inhaltsangabe

Purpose. Scope. Why Do We Test? What to Test. The Test Strategy. The
Development Lifecycle of a Test Specification. Recommended Content for
System Test Specification(s). Good Testing Practices. Supplier System Test
Reports/Qualification. The Use of Electronic Test Management and Automated
Test Tools. Appendices.