Resources

Four places to go deeper than this lesson, or to check a citation yourself before it goes in a real Lakeshore document. All four were checked and loading at the time this page was written.

• FDA guidance page: Data Integrity and Compliance With Drug CGMP — Questions and Answers — the same December 2018 guidance module 1 used, reused here for Questions 7, 8, and 11. Worth rereading Questions 1.c through 1.f in full alongside this lesson’s audit-trail material.

• 21 CFR 11.100, Cornell Legal Information Institute — the general requirements for electronic signatures: uniqueness, identity verification, and the certification-to-FDA requirement. Check this page directly before citing any of the three in a real document.

• 21 CFR 11.200, Cornell Legal Information Institute — the two-distinct-components and two-person-collaboration controls this module’s e-signature test actually turns on. The page most worth bookmarking from this lesson.

• 21 CFR 11.70, Cornell Legal Information Institute — the signature/record linking requirement, short enough to reread in full in under a minute, and easy to misquote from memory if you don’t check it here first.