Skip links

The Key Differences Between CFR Part 11 and Annex 11

The compliance landscape for electronic records and signatures is constantly evolving. Two key sets of regulations that have shaped this landscape are CFR Part 11 and Annex 11. While these two sets of regulations share some similarities, there are also important differences that businesses should be aware of. In this post, we’ll explore the key differences between CFR Part 11 and Annex 11. 

Key Differences Between CFR Part 11 and Annex 11 

  • CFR Part 11 and Annex 11 are two sets of regulations that govern electronic records and signatures. They are both widely used in the life sciences industry, but there are some key differences between them. 
  • CFR Part 11 is a set of regulations promulgated by the US Food and Drug Administration (FDA) that apply to all electronic records and signatures that are used in regulated transactions.  
  • Annex 11 is a set of guidelines promulgated by the European Commission (EC) that apply to electronic records and signatures used in the pharmaceutical sector. 
  • While both sets of regulations have the same goal of ensuring the integrity of electronic records and signatures, there are some key differences between them.  
  • CFR Part 11 is more prescriptive in nature, while Annex 11 is more flexible.  
  • Annex 11 also contains a number of exemptions that do not apply to CFR Part 11.  
  • CFR Part 11 only applies to FDA-regulated products and medical devices,  
  • Annex 11 covers all computerized systems within the European Union. 

High-Level Comparison of CFR Part 11 and Annex 11 

  1. Fundamental 
    • CFR Part 11: The FDA regulations applicable for use of electronic records and electronic signatures for all activities. 
    • Annex 11: Computerized systems are an integral part of GMP regulated activities and must be subject to validation and qualification processes to ensure compliance. 
  2.  Target
    • CFR Part 11: Using electronic records and signatures in computer systems – both open and closed – can help improve the efficiency and accuracy of data collection and processing. 
    • Annex 11: Risk-based quality management of computerized systems helps ensure that systems are effective and remain compliant with regulatory requirements. 
  3.  Goal
    • CFR Part 11: A computerized system should be just as effective as a manual system in terms of product quality and quality assurance, without increasing the overall risk. 
    • Annex 11: It is essential that electronic records and signatures be just as reliable and trustworthy as paper records and handwritten signatures. 

There are some areas in which CFR Part 11 and Annex 11 differ. 

These mainly relate to verifying the identity and accountability of individuals authorized to take action, as well as reporting to authorities.  

CFR Part 11 applies to electronic submissions to the FDA, while Annex 11 employs a risk management approach to criticality and focuses on periodic evaluations of systems.  

Annex 11 provides instructions, while CFR Part 11 has a more directive tone.  

Together, they form a comprehensive and useful guide for computer validation professionals, helping them to ensure compliance for their companies and clients. 


CFR Part 11 and EU Annex 11 are sets of regulations designed to ensure the safety and quality of electronic data. Achieving compliance with both sets of regulations can be challenging, but it is possible. If you need assistance, please contact us. 

Leave a comment