Title 21 CFR Part 11 (21 CFR 11) is the section of the Code of Federal Regulations (CFR) that deals with Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. It defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Ignition can use Active Directory for its authentication, which is part of 21 CFR 11. For more information, see 21CFR11 Ignition Compliance White Paper.
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Two-Factor Authentication (2FA) is a secure method of identifying users. A user's claimed identity is confirmed by using a combination of two different factors: 1) something they know, 2) something they have, or 3) something they are. Ignition 8 integrates with existing corporate IdPs that use 2FA to verify the identity of users.