Karen Ashworth, Director, Karen Ashworth Consulting has 16 years experience in the pharmaceutical industry, initially with a control system supplier and then as a validation consultant. Prior to that, she has experience as both a control systems designer and an operations manager within the nuclear industry. As a consultant, Ashworth has worked on control system projects for over 30 different end users and has experience using GAMP techniques over the full range of projects from small data monitoring systems through to large DCS systems and embedded control systems for complex machines. She has been an ISPE member since 2001 and was a member of the editorial group within the SIG that produced the GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition) and led the team that updated the GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems. (Second Edition).