An Introduction to 21 CFR Part 11

If you are connected to the life sciences industry in one way or another, you have undoubtedly heard of the USFDA’s  21 CFR Part 11 regulation. It applies to systems used in researching, manufacturing, and distributing product such as pharmaceuticals, medical devices, biological products (e.g. vaccines), blood, and tissue (e.g. organ transplants). FDA gave electronic signatures legal equivalence with traditional “wet ink” signatures on paper in 1997.


The FDA introduced the 21 CFR Part 11 regulation at the request of  industry. In the early 1990’s, the use of  computerized systems was increasing exponentially.  Companies wanted to reduce or eliminate the need for paper-based records and signatures. So they asked the FDA to provide guidelines for the use of electronic records and signatures.

The infographic below provides a brief history regulation thus formed by FDA. 



The rule has two main areas of enforcement: electronic records and electronic signatures. The rule applies to all areas of Title 21 of the Code of Federal Regulation (CFR) for all manufactured drugs and medical products distributed in the United States of America. 

It must be noted that using Electronic record keeping and electronic signature are not mandatory, but if used must comply with the regulations in 21 CFR part 11.

Let us decode the title “21 CFR Part 11”

  • 21:  Short for “Title 21,” which is the section of the CFR that applies to food and drugs. The CFR contains 50 “titles.” 
  • CFR: Short for “Code of Federal Regulations,” which is a set of laws published by the federal government of the United States.
  • Part 11: This part of Title 21 is specific to electronic records and electronic signatures, which includes electronic submissions to the FDA.

Requirements of Part 11

  • Use of validated existing and new computerized systems.
  • Secure retention of electronic records and instant retrieval.
  • User-independent computer generated time-stamped audit trails.
  • System and data security, data integrity and confidentiality through limited authorized access to systems and records.
  • Use of secure electronic signatures for closed and open systems
  • Use of digital signatures for open systems.
  • Use of operational checks.
  • Use of device checks.
  • Determination that the persons who develop, maintain or use electronic systems have the education, training and experience to perform their assigned task

Implications of 21 CFR Part 11 for the Industry

By introducing the 21 CFR Part 11 rule, the FDA have essentially enabled the Life Science community and other FDA regulated industries to streamline business processes, automate manufacturing supply chains, reduce turnaround time and costs,  reducing risk of human errors all by establishing standard criteria for the use of electronic records and signatures.  

However to utilize  these noteworthy  benefits,  FDA regulated companies must maintain requisite features in their systems, establish Standard Operating Procedures, and perform regular System Validation.  

Want to learn more about 21 CFR Part 11, and how achieve your own compliance 4.0 ?

The LeucineTech academy offers great training resources.  Check out the following links:

4 step guide to achieve Compliance 4.0

Posted on Jul 11, 2018 12:09:02 PM by Vivek Gera

Vivek Gera

Written by Vivek Gera

Vivek is the CEO of LeucineTech, a digital compliance platform that reduces the risk of drug FDA non-compliance (due to cross-contamination) by 80%.

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