21 CFR Part 11: 7 Ways To Avoid Noncompliance

The United States Food and Drug Administration’s (FDA) main guidance on electronic signatures and records, 21 CFR Part 11, has been around since the ‘90s. In the last 30 odd years, electronic record keeping has come a long way, from obscurity to the ordinary in many industries. Although technology is advancing rapidly, FDA regulations remain the same. Regulated industries still need to demonstrate compliance to predicate rules. They must continue to be vigilant in fulfilling Part 11 obligations and in producing safe and high-quality products.

Electronic records are all around in the lab and on the shop floor, though we may not think of them as such. If you use a computer workstation or other electronic device to record official test results, verify test batches, or even just sign-off on procedural documents, you’re beholden to 21 CFR Part 11. It is the only way life sciences manufacturers are allowed to officially keep electronic records and use electronic signatures to certify their work. If they’re out of step with the regulation’s requirements, they’re out of luck.

So, what can you do to ensure you’re compliant right now and remain compliant in the future? This industry brief outlines the 7 major elements critical to 21 CFR Part 11 compliance, how they relate to risks that pop up as noncompliance, and how MasterControl Quality Excellence, the #1 QMS software solution for life sciences, simplifies the compliance process to help you avoid slowdowns and undue scrutiny while doing the work to bring quality, lifesaving products to market.