Description
Validating Pharmaceutical Systems is a highly readable text that offers a pragmatic approach to the validation of automated/computerized systems, which is an essential step in maintaining compliance with global regulatory authorities, such as the FDA. It examines the different levels of automated systems used throughout the drug development, manufacture, and delivery life cycle using the GAMP-4 life cycle approach to their validation. Rich with case studies and real-life examples, it also supplies the reader with true applications of GAMP 4 to different areas of regulations, such as good laboratory practice, good clinical practice, good manufacturing practice, and good data practice.
