When Title 21 of the Code of Federal Regulation Part 11 went into effect in 1997, software providers were left wondering what it would do to their business practices and how it would change their processes. 21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the FDA guidelines on using electronic records and electronic signatures. Each title of the CFR addresses a different regulated area, 21 CFR relates to Pharmaceuticals and Medical Devices and Part 11 covers electronic records and electronic signatures.
To simplify, Part 11 ensures that companies and organizations implement good business practices by defining the criteria under which electronic records and signatures are considered to be accurate and authentic as compared to paper records and handwritten signatures.
According to the leading provider of life science consultants, Montrium, there are three main areas in which FDA regulated companies must look at as primary areas of focus when addressing 21 CFR Part 11:
When this code came out, most companies that it applied to were not excited, to say the least. Complying with Part 11 would mean changing processes, adding expenses, plus initial confusion over what parts applied to which procedures. In response, the FDA released a document to serve as a guide for observing Part 11. It has been updated through the years and the FDA has continued to release further guidance documents. The current rules were implemented as of April 2017.
What happens if you don’t follow 21 CFR Part 11?
FDA inspectors make regular visits to ensure that companies are in compliance with this regulation. If something does not comply, they will issue a Form 483. This is a warning, saying you need to correct certain areas. For the past several years, the FDA has issued around 5,000 483s annually.
It is important that everyone in the company, regardless of authority level, understands 21 CFR Part 11 and the key benefits that the regulation can bring to the organization.