Resources

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

• FDA guidance page: Data Integrity and Compliance With Drug CGMP — Questions and Answers — FDA’s own December 2018 guidance page for the source this whole module is built on. Read the full Q&A list once: this lesson only used the ALCOA, metadata, and “systems” questions, and the rest covers audit trails, static/dynamic records, and backups that later modules in this course pick up directly.

• 21 CFR 211.68, Cornell Legal Information Institute — the automatic/mechanical/electronic equipment section this curriculum has used since csv-and-becs, and one of the drug-CGMP sections FDA’s own footnote ties to ALCOA’s “accurate” element. Worth rereading alongside this lesson’s citation decoder.

• 21 CFR 210.2, Cornell Legal Information Institute — the supplementation clause that lets a drug-CGMP guidance like this one reach a blood establishment’s own records at all. Already the subject of its own full lesson in gamp5-and-the-v-model; this page is here so you can check the exact text yourself without re-deriving it.