What is 21 CFR Part 11 and How Does it Affect Me?

Have you heard of 21 CFR Part 11? If not, it is a set of compliance requirements that allow for safe and secure storage and submission of electronic records for industries regulated by the US FDA. In other words, this is the FDAs procedure for quality control of electronic data. Any company storing electronic data that could be audited by the FDA must comply with this set of requirements. Although the FDA still permits paper-based data storage and submission, this approach can lead to higher costs, increased time to market, decreased quality, and challenges with information storage availability, retrieval and portability, as compared with electronic methods.

But don't worry; there are two ways to approach this requirement:

Partial Electronics - this approach stores the electronic records as equivalent to paper records with handwritten signatures. It still requires a large amount of printed documentation that carries the same risks & challenges as a full-paper approach.

Electronic - this approach uses all electronic records and electronic signatures, so no paper documentation is necessary. This approach is less subject to human error and can save significant time and money with automation of processes. Additionally, a completely electronic approach allows for electronic submission of data and reports to the FDA, which can save additional time and costs to the organization.

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Originally posted on March 16, 2012 , Updated On March 23, 2021