Resources: Change control for regulated systems

Each link below was checked this session and loads.

• 21 CFR 606.100 — Cornell Legal Information Institute — the SOP (standard operating procedure) regulation this module’s citations both come from: the “establish, maintain, and follow” requirement in paragraph (b), and the sentence requiring procedures to be available where they’re performed. Local verbatim copy: sources/cfr/606.100.md.

• AABB Quality Systems Framework (2021, public discussion draft PDF) — AABB’s own public description of the ten Quality System Essentials, including QSE 5, Process Control, the home of change control in this module. Use it to see the theme and scope of Process Control in AABB’s own words; don’t cite a standard number from it — see sources/aabb/qse-framework.md for why.

• GovInfo: Code of Federal Regulations collection — the U.S. Government Publishing Office’s official CFR collection. Use it as a fallback primary source if eCFR or Cornell is ever unreachable, or to pull an official PDF of a full CFR part for the record.