Testing Computers Systems for FDA/MHRA Compliance

Providing a thorough review of automated systems testing to meet the regulatory requirements of the FDA and MCA, this title focuses on software module, software integration, hardware, and system acceptance testing. It covers best practices in computer systems testing for the pharmaceutical and related healthcare manufacturing industries.

Klappentext

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