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 four-part legacy-system test, its changed-system sentence, and its “Copies of Records” section all come from. Use it when you want the full “Legacy Systems” and “Copies of Records” sections in context, alongside the predicate-rule material last module already pulled from the same document.

• 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 and the pH-meter/FT-IR comparison (Question 10) module 3 quoted in full and this module applies directly to Lakeshore’s own legacy instrument. Reread Question 10 here if you want the original pH-meter and FT-IR language side by side with this module’s own resolution.

• Cornell Legal Information Institute (LII): 21 CFR § 11.10 — https://www.law.cornell.edu/cfr/text/21/11.10. A clean, citable, non-FDA rendering of the full closed-systems control list, including paragraph (b) (the copy-generation requirement this module’s “Copies of Records” section names, but doesn’t re-quote in full) and paragraph (e) (the audit-trail requirement module 2 already reconciled with the predicate rule underneath it).