Continuous monitoring system compliance with Part 11 and Annex 11: Easier than you think

Monitoring in Part 11 and Annex 11 regulated environments
Life Science

The past 30 years have seen regulators of GxP environments creating guidance to accommodate new technologies that are increasingly adopted in regulated industries. The FDA and the European Commission published 21 CFR Part 11 and Annex 11 respectively to ensure that computerized and automated systems did not create more risk than manual paper-based systems. Meanwhile, vendors of continuous monitoring systems for regulated environments, like Vaisala, have risen to the dual challenge of both regulations, while meeting the operational needs of GxP-regulated organizations by ensuring systems include risk-reduction features such as:

• Document signature options
• Record Protection
• Limits to System Access
• Audit Trails
• Operational Checks
• Authority Checks
• Device Checks
• Training modules

These, along with other features that aid in compliance, have changed how environments are monitored and how companies can reduce risk to product efficacy.  However, even with the inclusion of system features that aid in compliance, the responsibility to comply with GxP regulations still depends predominantly on how a system is deployed, used, and maintained. In this webinar, we’ll breakdown the requirements of 21 CFR Part 11 and Annex 11 as they relate to environmental monitoring systems and show how simple compliance with the “Elevens” can be with the proper use of your monitoring system.

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Paul Daniel, Senior Regulatory Compliance Expert

Paul Daniel

Senior Regulatory Compliance Expert

Paul Daniel is the Senior Regulatory Compliance 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 also shares his GMP experience through regular blog contributions, webinars, and seminars around the world. Paul’s expertise in the demanding GxP world is applicable to any industry where measurement is critical to product quality. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.