Title 21 CFR Part 11: What is it and why is it important?
What is it?
The FDA is a government regulatory authority and CFR is short for “Code of Federal Regulations” which is basically another work for Federal Law. Each Cabinet in government and governmental body has a Title in the CFR that dictates the laws that apply to a particular governmental body so the first part of this CFR 21 is basically CFR Title 21, which is the body of laws under which the FDA is regulated. the second part (“Part 11”) is a sub-section under the law that is applied to specific circumstances. Part 11 in this case applies to Clinical Trials and electronic record keeping for clinical trials.
Sec. 11.1 Scope.
(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means.
An interesting thing about CFR 21 Part 11 or more specifically and generally referred to as Part 11 compliance is that there are 2 points of view.
1 – it is just a law and has some ambiguity at that, you can see the law here: Law :and information here: Title 21 CFR Part 11, it is very small barley fits on 2 pieces of paper and has enormous consequences for software used in the regulated area of Clinical Trials.
2 – Whenever you have a legal area there is what the law says and second is the interpretation of the law, or more specially the interpretation and enforcement of the law.
You have cases that have been taken to court and interestingly enough have had impact on how things are enforced and what you need to do to come under compliance. One such court case : here, essentially explains that you cannot grand-father electronic systems into compliance because of the risks and downstream effect, so this court case says that any systems that fall into compliance need to meet the new laws circa 1998.
What is this important?
If you wanted to innovate and differentiate yourself in this industry there is a big barrier to entry and interestingly enough regulatory compliance is expensive and also risky business so it creates a value moat if you can understand and use regulatory compliance to your advantage.
If you can pass a Part 11 Audit it has extreme value to show not only that your software does what it says it does, it does what the law requires, which ensures safety, security and proper function.
The most important part of this regulation is that you need to be certain that data in a clinical trial are true and exact, this impacts whether people live or die. Because of high risk and importance of the software systems once you get a system compliant it reaps enormous benefits in that you charge more money for the software, training, and validation of the system setups.