What is 21 CFR Part 11?
21 CFR Part 11 outlines the federal requirements that help to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
Does 21 CFR Part 11 apply to me?
The first step in becoming compliant with the regulations is to determine whether or not you are required to be compliant. The following questions can help lead to the determination:
If you answered yes to any of these questions, your electronic systems of record that are being used to meet predicate rules are required to comply with 21 CFR Part 11.
The second step of the process is to identify the computer systems you are using in your clinical trial.
Addressing the following can help identify all of the computer systems associated with your trial:
Page II: Click here to find out what software features are necessary to be 21 CFR Part 11 compliant
Page III: Click here to see an example process of system validation
Please Note: Not validating your electronic system(s) of record may result in regulatory citations. If you have any questions or concerns about your system, it is highly recommended that you contact the CTRC for guidance