Case Study
FDA 21 CFR Part 11 Compliance
FDA 21 CFR Part 11 Compliance SciNote is proud to be chosen as the solution used at the FDA, one of the leading United States federal executive departments. Researchers at the FDA are at the forefront of today’s scientific progress, responsible for protecting and promoting public health. We are honored to support their work. Introduction SciNote Premium plans include a 21 CFR Part 11 add-on that provides a toolset for compliance with the 21 CFR Part 11 regulations, while still keeping SciNote flexible and easy to use. The 21 CFR Part 11 add-on includes the following features: electronic signatures, electronic witnessing, audit trails and system log records. According to the FDA guidelines, electronic signatures are considered to be trustworthy, reliable, and generally
