Resources: Internal audits and management review

Four external links, each checked this session for a working response.

• 21 CFR 606.100, Standard operating procedures — Cornell Legal Information Institute The full text of the section behind this module’s one citation — paragraph (c)’s “thorough investigation… conclusions and followup” requirement, the same regulatory floor under every deviation this course has covered, including one discovered through internal audit. Use this when you want the regulation’s exact wording without the eCFR site’s own navigation chrome.

• GovInfo: Code of Federal Regulations collection The U.S. Government Publishing Office’s official CFR collection — the fallback source when eCFR itself is unreachable, and the version courts and agencies treat as the authoritative annual compilation. Use it to browse Title 21 by year or confirm a citation against the official printed edition.

• AABB: Updated Quality Systems Essentials AABB’s own public page describing the 2023 update to the QSE (Quality System Essential) template — the framework this module’s two QSEs, Assessments: Internal and External and Organization, come from. Use it for the plain-language description of why and how the template changed; it doesn’t list the ten QSE titles itself (see the framework PDF below for that).

• AABB: PROPOSED Quality Systems Framework (2021 discussion draft PDF) The public document sources/aabb/qse-framework.md was built from — spells out all ten QSEs, including QSE 8 (Assessments: Internal and External) and QSE 1 (Organization, which names management review), each with a short “Key Concepts” description. Read it for the structure and themes only; it’s a proposed discussion draft, so don’t cite a standard number from it as current or adopted.