Karen Ashworth

Karen Ashworth Consulting Ltd
Director
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 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 Good Practice Guide: Testing GxP Systems (Second Edition) and the GAMP 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 GAMP5 Second Edition.

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Features
When Is a Category Not a Category?

Categorization offers a useful starting point for assessing the risk of failure for individual software components, but it is not a validation checklist. Organizations must apply critical thinking to combine categorization with risk assessment and supplier assessments to appropriately scale life cycle activities and manage risk.