Currently browsing "21 CFR Part 11"
-
Training Records and 21 CFR Part 11 Compliance: What Organizations Should Know
21 CFR Part 11 applies to all digital records within your life science business. That includes your learning and development initiatives. It is important to understand how the FDA’s rules affect training records, including their storage, access, and more. Of course, navigating this area can be confusing, so we created a guide to help ensure […]
-
How eLeaP Complies with FDA’s 21 CFR Part 11
Life science companies are required to adhere to FDA’s 21 CFR Part 11 when it comes to digital record storage and access. These rules were handed down as part of the FDA’s strategy for reducing the risk of data breaches and information exposure. However, many companies struggle to understand how the rules apply to them […]