Karen Ashworth graduated from Jesus College, Cambridge in 1989. During her time at Cambridge her achievements included a foundation scholarship as well as the Percival Prize for engineering. She gained chartered engineer status in 1994.


Prior to setting up Karen Ashworth Consulting , Karen had already spent 12 years in the control systems industry and gained deep understanding of the industry from the perspective of both an end user and a supplier of control systems.

Initially she worked on a control refit for the main nuclear fuel reprocessing plant at Sellafield, taking responsibility for meeting handover dates in a £1 million a day shutdown. Karen then moved to run a shift team of 25 on the Sellafield vitrification plant. Here, she was responsible for achieving safety, production, quality, and maintenance targets in complex plant where radiological conditions require all work to be done remotely and where detailed batch records are required to guarantee product quality during thousands of years of storage.


Following a move to Eurotherm in 1994, Karen specialised in the management of control systems projects for major pharmaceutical industry clients including validation to FDA standards and batch control to IS88.01. It was here that Karen developed the expertise in control system validation which led her to set up Karen Ashworth Consulting in October 2000.


As a consultant, Karen has worked on control system projects for over 30 different end users worldwide and has experience using GAMP®5 techniques over the full range of projects from small data monitoring systems through to large DCS systems and embedded control systems for complex machines.

Karen is a member of the UK GAMP®5 CoP Steering Committee. Over the last 2 decades, she has contributed to numerous GAMP®5 special interest groups including:

o Being part of the editorial group for the Good Practice Guide ‘Testing of GxP Systems’ and one of the speakers for the Copenhagen launch conference.
o Contributor to the Good Practice Guide ‘GxP Process Control Systems (2nd Edition)’
o Co-lead for the update team who produced Good Practice Guide ‘Testing of GxP Systems (2nd Edition)’
o Lead for the team who produced the process control system content for Good Practice Guide ‘Data Integrity – Manufacturing Records’
o Contributor to the Good Practice Guide ‘Enabling Innovation’
o Contributor to GAMP®5 2nd Edition