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21 CFR Part 11 vs. EU Annex 11: What’s the Difference?


The pharmaceutical and healthcare industries are highly scrutinized and maintained by regulatory bodies because of their nature of work and the inclusion of public safety in the process. As the world becomes more digital, the healthcare industry is adopting electronic counterparts for certain procedures and document management. This includes the adoption of electronic documentation, the development of machinery, and more.

However, because machines are involved in the process, safety and quality adherence must be on point, not to mention the fraud that can occur as a result of electronic record leakage. Keeping these in mind, the FDA issued a regulation called 21 CFR Part 11 in 1997, and its European counterpart was released the same year as well.

What is 21 CFR Part 11?

21 CFR Part 11 is an FDA-approved regulation that was introduced in 1997 to educate medical and healthcare companies about the importance of electronic signatures and records in ensuring accuracy and avoiding fraud. The 21 CFR Part 11 regulation is a detailed document that outlines all of the rules and scope of the regulation to ensure complete compliance.

History of 21 CFR Part 11

  1. Origin and Purpose
    After a few cases were filed against key players in the healthcare industry for manipulating the results of their drugs and other electronic records, 21 CFR Part 11 came into the picture. This raised serious concerns about the system’s authenticity. The loophole was clearly visible. The main reason the FDA (Food Drug and Administration) created 21 CFR Part 11 in 1997 was to provide clear guidelines on how electronic records and signatures in computer systems should be used, maintained, and distributed.
  2. Scope of Applicability of the Regulation
    21 CFR Part 11’s scope includes all types of electronic documentation created for trials, processes, records, and other components of the pharmaceutical, healthcare, and biotechnology industries’ internal and external record-keeping. These regulations apply to all industries that are controlled and governed by the FDA in the US. Companies are given a framework for how this rule, also known as an annexure, must be applied across an organization’s record-keeping function. Any inapplicability can result in a product recall, fines, or lawsuits against the company if audits happen due to any mishap.

What is EU Annex 11?

21 CFR Part 11’s European counterpart is known as EU Annex 11. The foundations of this regulation were laid and improved to go beyond electronic documents and cover the procedures used to create computerized medical devices. The EU Annex 11 compliance requirement instructs that the product maintain the desired quality during the electronic process.

History of EU Annex 11

  • Origin and Purpose
    EU Annex 11 was created in 1997 to ensure that EU countries followed Good Manufacturing Practice (GMP) for computerized procedures and manufacturing. However, with the advancement of technology, the rule was updated numerous times to remain compliant with the EU government’s 2008 change in the GMP. The latest version was released in 2011 and had a goal of improving accuracy and efficiency across the entire lifecycle.
  • Scope and Applicability of the Regulation
    The scope of EU Annex 11 encompasses general guidelines, risk assessment, data management, security, and computerized activities. This rule is an expanded version of the FDA’s rule, with additional properties as well as the validity and reliability of online signatures.

Major Differences between 21 CFR Part 11 and EU Annex 11

Although one appears to be an expanded version of the other, there are some significant differences between the two. Here are four such major distinctions:

  • Regulatory Requirements
    21 CFR Part 11 requires companies that want to sell their product in the US to follow the regulatory guidelines for their electronic documents. These documents can be tampered with, accessed by third parties, or be vulnerable to cyber-attacks, because of which they need to be protected.
    The regulatory requirement for EU Annex 11 encompasses all necessary requirements, such as system documentation, validation, security, and so on. This compliance is required due to the government’s stringent guidelines for the pharmaceutical and healthcare industries.
  • Audit Trails
    According to 21 CFR Part 11, audit trails for documents of concern must follow a standardized process for modification, creation, and upkeep of electronic records. That said, 21 CFR Part 11 provides detailed legal audit guidelines. EU Annex 11, on the other hand, is more of a best practices agreement for computerized processes.
  • Electronic Signatures
    In accordance with 21 CFR Part 11, electronic signatures must be as reliable and trustworthy as written records. The focus of EU Annex 11 is on computerized system management, which includes electronic signatures.

Major Similarities between 21 CFR Part 11 and EU Annex 11

Here are some major similarities to know about:

  • Quality Assurance
    This is integral to both rules: to create records, processes, and systems of the highest quality and reliability.
  • Record-Keeping Requirements
    Record-keeping is an essential requirement in both rules for creating, maintaining, and saving records and getting through audit trails.
  • Security Requirements
    Because the rules are centered on electronic documentation, data security must be kept intact for paperless records.

LMS Considerations for 21 CFR Part 11 Compliance and EU Annex 11 Compliance

A learning management system must be compliant with 21 CFR 11 and EU Annex 11 in order for training records and documents to be safe and the organizational process to be regulatory compliant. Here are some LMS considerations for following the rules.

  • Requirements for Developing Effective eLearning Courses
    The LMS must allow for the uploading and creation of documentation, as well as the creation of other training materials as needed for the eLearning courses. Maintaining a repository of all these knowledge assets must be a top priority for compliance.
  • Strategies for Creating Secure User Accounts
    In order to provide data security, an LMS must implement strong username and password requirements. To create more secure accounts, two-factor authentication must be available in the LMS system.
  • Building Audit Trails for Tracking Learner Progress
    The learning management system must be capable of tracking every learner’s progress. The software should be equipped with reporting capabilities, which can be helpful during audit trails.
  • Utilizing Digital Signatures for Authentication
    An LMS must be able to provide electronic signatures for various types of document signatures and changes. This electronic signing must adhere to the rules outlined in the two regulations.

Which Compliance Should I Follow?

For any organization unsure about which compliance to follow, considering the annexure based on the company’s operations proves viable in making the decision. If the operations and distribution are based in the United States, then adhering to 21 CFR Part 11 is a viable option. However, if the demographic spans both the United States and the European Union, both regulations must be followed. When it comes to compliance, a variety of factors must be considered, such as risk management, valid processes and procedures assessment, and periodic audits.


Gyrus provides robust LMS software (GyrusAim) that complies with government regulations, making your company’s operations compliant. Our LMS is secure, and the reporting mechanism makes it simple to audit the company’s training initiatives and the associated procedures. Schedule a demo to learn more about the features of GyrusAim.


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