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.

• 21 CFR 11.10, Cornell Legal Information Institute — the full closed-system controls section this lesson quotes from: (d) access limits, (f) operational sequencing checks, (g) authority checks, (h) device checks, plus (a), (e), (i), (j), and (k) named but not re-taught here. Read it in full to see all eleven controls sitting together, not just the four this module spends its depth on.

• 21 CFR 11.3, Cornell Legal Information Institute — Part 11’s definitions section, including closed system (b)(4) and open system (b)(9), the distinction this lesson’s vendor-remote-access question turns on. Read the surrounding definitions too — “electronic record” and “electronic signature” are worth having exact before data-integrity-and-records builds further on them.

• FDA guidance page: Part 11, Electronic Records; Electronic Signatures — Scope and Application — the 2003 guidance this lesson quotes for FDA’s enforcement-discretion posture and its “we intend to enforce” list. Worth reading in full once: it’s short, it’s still the current guidance on this topic, and it explains its own reasoning for narrowing Part 11’s scope, not just the bullet list this lesson pulled from it.

• FDA guidance page: Blood Establishment Computer System Validation in the User’s Facility — the same BECS guidance this course has used since module 1, the source for this lesson’s training sentence (III.G) and remote-access-log recommendation (III.B). Worth rereading section III.B in full for the rest of its system-documentation list, which module 3 covered and this lesson only used the tail end of.