Testing Computers Systems for FDA/MHRA Compliance (Computer Systems Validation Life Cycle Activities)

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.