Resources: Reviewing a validation package

Each link below was checked this session and loads.

• 21 CFR 11.10 — Cornell Legal Information Institute — the full “Controls for closed systems” section this module draws three clauses from: the introductory sentence (the obligation sits on “persons who use” a system, not its vendor), paragraph (a) (validation for “accuracy, reliability, consistent intended performance”), and paragraph (k)(2) (time-sequenced systems documentation, named as a concept only). Local verbatim copy: sources/cfr/11.10.md.

• GovInfo: Code of Federal Regulations — the government’s own dated, authenticated CFR collection. Use this when you need a citation tied to a specific published edition, not just the current rolling text Cornell’s LII shows.

• AABB Quality Systems Framework (2021, public discussion draft PDF) — AABB’s own public description of the ten Quality System Essentials, including QSE 3 (Equipment, which explicitly covers IT systems and their qualification) and QSE 5 (Process Control, which covers validation). Use it to see the theme and scope of each QSE in AABB’s own words; don’t cite a standard number from it — see sources/aabb/qse-framework.md for why.

• AABB: Updated Quality Systems Essentials — AABB’s current landing page on the QSE structure. Use it as a starting point for confirming which edition’s chapter titles and numbering are currently in force before citing one precisely in a real Lakeshore document; see sources/aabb/qse-framework.md’s verification notes for what’s still unconfirmed.