In this week's blog, Senior Regulatory Expert Paul Daniel gives a brief (very brief) overview of 21 CFR Part 11 and Annex 11. Paul has Part 11 on the brain because he is currently updating our White Paper on how our monitoring solution handles the requirements of the regulation -- the next version will include EMA's Annex 11.Paul writes:
Stay tuned for an updated version of our White Paper: "Assessment of Vaisala Veriteq viewLinc Continuous Monitoring System Compliance to 21 CFR Part 11 Requirements".
We received a great email from one of our blog readers. Here is a comment from blog reader Christopher R. Lee.
Thank you, Mr. Lee, for sending us your comments! (posted below)
Paul's reply to these comments was:"Very cool! I like his viewpoint -- seems like a front-line explanation of a risk-based approach, combined with the experience of someone who has had to ensure quality both within and outside of a strict corporate structure." PD
Christopher R. Lee wrote:
Paul Daniel is the Senior GxP Regulatory Expert at Vaisala. He has worked in the GMP-regulated industries for over 20 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems. At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.