Resources

A few primary sources to keep handy, each checked to load before being listed here.

• FDA guidance: Part 11, Electronic Records; Electronic Signatures — Scope and Application (2003) — https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application. The guidance this module’s predicate-rule definition, narrow-interpretation passage, and documentation recommendation all come from. Use it when you need the full context around any of those quotes, or when you want to read the legacy-system and copies-of-records sections ahead of next module.

• FDA guidance: Data Integrity and Compliance With Drug CGMP: Questions and Answers (2018) — https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers. Source for the static/dynamic distinction (Question 1d) and the paper-printout-from-stand-alone-instrument answer (Question 10) this module quotes. Also where modules 1 and 2’s ALCOA and audit-trail material came from, if you want one document covering all three.

• Cornell Legal Information Institute (LII): 21 CFR § 11.2 — https://www.law.cornell.edu/cfr/text/21/11.2. A clean, citable, non-FDA rendering of the exact regulation quoted in full above — useful to hand a colleague who wants to read 11.2 on its own, outside this course’s framing.