Karen Ashworth, Director, Karen Ashworth Consulting has over 25 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, Karen has worked on control system projects for over 30 different end users 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.

She has been an ISPE member since 2001 and led the teams that produced the GAMP®5 Good Practice Guide: Testing GxP Systems (Second Edition) and the GAMP®5 Good Practice Guide: Data Integrity – Manufacturing Records.

More recently she has been part of the teams who produced the ‘Enabling Innovation’ Good Practice Guide and provided the updates for GAMP®5 Second Edition.




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


Assistance with all stages of control system validation from design requirements through to validated system.

o Control system validation assistance
o GAMP®5 documentation
o Independent documentation / code review
o Test protocols
o 21 CFR part 11 review / remediation
o Data Integrity risk assessment
o Periodic Review


Courses tailored to your products and your audience – whether it is day-to-day users, sales force, project managers or site service engineers.
o Process control systems for GxP envirinment.
o Data integrity.

Management of control systems projects to ensure compliance with GAMP®5 and / or with clients’ internal validation procedures.

Software design, implementation, integration and testing to GAMP®5 or to clients’ internal standards.

o Object oriented analysis
o Clear design documentation
o Structured programming
o Tight change control
o Fully documented testing
o Traceability throughout project


I have worked with Karen through much of my 20 year involvement in the ISPE GAMP®5 technical community of practice. We have co-authored and co-led GAMP®5 Good Practice Guides together during that time, and presented at ISPE conferences around the world.In my personal opinion, Karen is a true expert in the validation of process control systems. Her practical approaches and breadth of experience provide her customers with exactly the right-sized validation approach in support of their intended use.Charlie Wakeham

Co-Chair, ISPE GAMP®5 Global Steering Committee

“The best validation documentation I have ever seen from a supplier.”
End user’s validation officer on a project managed by Karen Ashworth Consulting Ltd on behalf of Eurotherm Limited.

“I have had the pleasure of working with Karen on many and various projects over more than 2 decades. Karen’s project management skills are exemplary. Professionalism, attention to detail, and safety consideration are part of Karen’s DNA. Ask anyone that has ever worked in Karen’s team and they will reassure you that your project will be in excellent hands.”

Penny – colleague

“Eurotherm required consultancy advice to launch a new product into the pharmaceutical market. We needed an objective view on our R&D; development and product specification. Karen Ashworth Consulting Ltd provided this service by working directly with all parts of the company; creating an offering that has been very attractive to our customers.”
Rob Rennie Regional Manager, Eurotherm Limited

“There are four attributes which I require in any software project:

1. A clear understanding of the task to be automated;
2. Clarity of thought to implement the task;
3. A clear structure in the programming;
4. Documentation which makes the system fully accountable.

These are always evident in work delivered by Karen Ashworth Consulting Ltd and demonstrate total commitment to customer projects.”
Charles Monroe, Director, Monroe Brothers Ltd.

“Of seven control systems projects managed by Karen Ashworth, all have been delivered on time and within budget. During all project stages (including specification, configuration, acceptance test and commissioning) the impact on our resources was minimal and the quality of the product was first class.
I have also been impressed by Karen’s strengths in gaining customer confidence and becoming “part of the team”. She is pro-active in establishing a detailed understanding of functional requirements and recognises the importance of developing strong working relationships at all levels. Coupled with continuity of management, this is a vital ingredient for the success of any project.”

Mick Baldwin, Logistics Manager, AH Marks & Co Ltd

“Karen is a born Critical Thinker. Whatever she does (design, implementation, testing, project management, training) is done in thoughtful and optimised manner. This approach enables her to always deliver to a high quality with utmost efficiency. She is also hard working, reliable and consistent”

Hilary Mills-Baker
Co-lead for the GAMP®5 Good Practice Guide
GxP Process Control Systems 2nd Edition and UK GAMP®5 CoP Vice Chair

“Karen has supplied her Engineering Services to our business and to our end Customer sites utilizing GxP processes over many years. We have had many compliments about the standards of work provided and excellent understanding the system and processes involved”

Global Technical Support Manager for a long standing customer.


Contact us:
Telephone: 01444 248090
Mobile: 07740 902501
Email: Enquiries@karenashworth.co.uk