Resources: What your QA produces, and who owns it

Each link below was checked this session and loads.

• 21 CFR 606.100 — Cornell Legal Information Institute — the source for this module’s central contrast: paragraph (c)’s first sentence (product-record review before release) versus its second sentence (the thorough, documented investigation of a discrepancy). Local verbatim copy: sources/cfr/606.100.md.

• 21 CFR 11.10 — Cornell Legal Information Institute — the full “Controls for closed systems” section this module’s paragraph (j) comes from: written policies holding individuals accountable for actions taken under their electronic signatures. Local verbatim copy: sources/cfr/11.10.md.

• 21 CFR 606.20 — Cornell Legal Information Institute — the Personnel section behind this module’s competence floor: paragraph (b)’s “adequate in number, educational background, training and experience” standard. Local verbatim copy: sources/cfr/606.20.md.

• AABB Quality Systems Framework (2021, public discussion draft PDF) — AABB’s own public description of the ten Quality System Essentials, including QSE 1 (Organization) and QSE 2 (Resources), the two this module draws on for executive responsibility and competence. 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.