21 CFR Part 11 & Annex 11 for Monitoring Systems


Understanding 21 CFR Part 11 & Annex 11 is not as daunting a task as it seems, we receive many questions on the topic. This learning module offers background and overview of the "elevens".  Part 11 and Annex 11 were introduced to address the key differences between computerized and manual systems and make electronic records equivalent to paper records as evidence of quality process and execution.  Today most environmental monitoring systems used in GxP-compliant firms are inherently aligned with the requirements of both the "Elevens."  However, the risk comes not from the systems themselves, but in how they are implemented and maintained.  

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

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
• Audit Trails 
• See them all....

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21 CFR Part 11 Annex 11 viewLinc

21 CFR Part 11 compliance for environmental monitoring software functions vs. operating procedures

From Validation to Assurance.  Be a part of the next wave in regulatory focus on electronic records as the switch from CSV(Computer Systems Verification) to CSA (Computer Systems Assurance) takes shape.  Learn more about the latest changes and how they have exposed the risks inherent to computerized systems with documentation strategies that were designed for mechanical equipment.  Connect the dots on how GxP-regulated industries have responded to regulatory changes.  

Application Note: 21 CFR Part 11

Annex 11 compliance for environmental monitoring systems: Beyond electronic records and signatures

Truth: Annex 11 is not just the European version of the US FDA's 21 CFR Part 11.  Annex 11 in reality has a broader scope than Part 11.  Annex 11 pertains to more than electronic records and takes a more holistic system life cycle perspective with a focus on risk assessment as a tool for ensuring product safety and efficacy.  As a part of European Good Manufacturing Practice, Annex 11 outlines the proper use of computerized systems used in GxP-regulated industries.  Diversify your perspective and implement best practices in your facility today.    

Application Note: Annex 11
Annex 11

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