Resources

External links for this lesson. All checked to load from a plain request as of the date this page was written. (Note: eCFR’s and fda.gov’s own rendered sites block automated/proxied traffic with a bot check in this repo’s build environment, even though a human browser reaches them fine; the regulation text quoted in this lesson comes from eCFR’s public Versioner API instead, and the links below use verified-loading mirrors of the same official text.)

• Cornell LII: 21 CFR 606.100, current text — the standard operating procedures requirement this lesson applies to BECS directly. Use this to check the current text, since regulations get amended and the copy in this repo’s sources/ folder is a dated snapshot.

• Cornell LII: 21 CFR 11.10, current text — the “controls for closed systems” section, including the systems-validation clause this lesson quotes. This module names Part 11 only briefly; Track 3 (csv-and-becs) covers the full electronic-records framework this section sits inside.

• Cornell LII: 21 CFR 606.171, current text — the biological product deviation reporting section this lesson applies to a software defect, already covered in full in the risk-and-controls-vocabulary foundation lesson.

• GovInfo: Code of Federal Regulations — the U.S. Government Publishing Office’s official, legally authoritative annual CFR archive. Use this for the official, dated, legally citable version of a specific year’s text — for example, to confirm exactly what a section said on the date of a past inspection or a vendor change.