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Why the US FDA is Rethinking 21 CFR Part 11 and What Can We Do Now?

Much discussion has ensued regarding 21 CFR Part 11, the FDA's withdrawal of the guidances, and the intent of the new guidance. Rather than revisiting this topic I intend to expound upon why the FDA is revisiting Part 11, what our industry did to exacerbate the situation, and how we can move forward rationally while the FDA redefines the scope of Part 11.

Why is the US FDA Rethinking Part 11?

When the regulation was first issued there was a lot of discussion but little actual movement towards implementation. Then the first few warning letters started to emerge and people began to look for answers on how to proceed with compliance. As with most compliance processes in the life sciences sector, we started by making lists of affected systems so that we could evaluate risks and assign priorities. We called it 'compliance assessment'.

Not sure what was going to be relevant and what wasn't, we started by listing all computer systems we could think of. After all, if a system did not have to be Part 11-compliant we could take it off the list, right? Lack of experience with Part 11 and the evolution of understanding of electronic records unfortunately resulted in many irrelevant systems remaining on the lists. People could rationalise that any information in a computing system was somehow an electronic record. Valuable resources were spent trying to establish remediation processes for computer systems that did not really use electronic records!


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By Ray Miller, President of Miller Regulatory Consulting, Inc

Ray Miller is President of Miller Regulatory Consulting, Inc, responsible for recognising and applying emerging technical capabilities and trends to greatly improve systems and processes in the life sciences industries. Throughout his 25 years in the life sciences industry, Ray has synergistically bridged diverse technical specialities through the co-ordination of people, hardware and software. His previous roles include Vice President and Chief Technology Officer at Cetan Technologies and Director of IT and Computer Validation for AAI, Inc, where he created AAI's computer validation practices in compliance with FDA expectations, which was spun off to form Cetan Technologies. Dr Miller earned a PhD in Analytical Instrumentation from the University of Cincinnati and has attended the Graduate School of Business at Stanford University. He is a frequent lecturer on 21 CFR Part 11 and computer systems validation regulatory compliance.

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