21 CFR Part 11 Compliance
21 CFR (Code of Federal Regulations) Part 11 is a regulation issued by the United States Food and Drug Administration (FDA) that outlines the requirements for electronic records and electronic signatures in certain industries. In other words, this regulation ensures the security, authenticity, and reliability of electronic records and signatures in FDA-regulated industries.
Is Tovuti LMS 21 CFR Part 11 compliant?
21 CFR Part 11 compliance applies to organizations operating within the scope of the United States Food and Drug Administration (FDA) regulations.
Tovuti, a Software as a Service (SaaS) organization, is not subject to FDA regulations. As such, Tovuti LMS can help support organizations in meeting compliance regulations by providing tools that make it easier to stay in good standing with the requirements of 21 CFR Part 11.
What tools does Tovuti LMS provide to support 21 CFR Part 11 compliance?
Tovuti LMS provides e-signature functionality and easily-searchable records that organizations subject to 21 CFR Part 11 can use to better organize their training program and avoid potential regulatory noncompliances.
What organizations are subject to 21 CFR Part 11 compliance?
The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. It also has the responsibility of maintaining the safety of our nation's food supply (human and animal), tobacco products, cosmetics, and products that emit radiation.
The FDA may use 21 CFR Part 11 compliance as part of its regulation of organizations and products within these industries.
Source: fda.gov
