Data Integrity and Compliance With Drug CGMP: Questions and Answers — Guidance for Industry¶
U.S. Food and Drug Administration. (2018). Data Integrity and Compliance With Drug CGMP: Questions and Answers — Guidance for Industry: Questions and Answers.
Cited by¶
2 citations across 2 artifacts.
Each citation links to the sentence it supports in the citing article.
Primes¶
- Evidence-Fidelity Decay
- in laboratory notebooks (a bench entry during a run is dominated by observation; an end-of-day reconstruction blends observation, rationalisation, and reconstruction),
This sourceCodifies the ALCOA principle that records be 'contemporaneous' — recorded at the time of the activity — because entries written later from memory are a principal data-integrity failure, the lab-notebook analogue of delayed reconstruction.
- in laboratory notebooks (a bench entry during a run is dominated by observation; an end-of-day reconstruction blends observation, rationalisation, and reconstruction),
Mechanisms¶
- Lab Notebook Record
- Its strength is capturing the situated truth of a run — the deviations, materials, and judgments that no prospective document anticipates — following the spirit of data-integrity principles that records be attributable, legible, contemporaneous, original, and accurate.
This sourceRequires CGMP data to be attributable, legible, contemporaneously recorded, original or a true copy, and accurate.
- Its strength is capturing the situated truth of a run — the deviations, materials, and judgments that no prospective document anticipates — following the spirit of data-integrity principles that records be attributable, legible, contemporaneous, original, and accurate.
Verification¶
Does it exist? Not checked yet. This entry carries no identifier to resolve. It was extracted from the citation as written in the article, normalized, and deduplicated against the rest of the registry.
Does it back the claim? Not recorded. Neither this nor any other of the 2 citations of this work carries a recorded support check.
Support is checked per citation rather than per work — the same source can be cited soundly in one article and wrongly in another. Per-citation recording began recently, so a citation with no recorded check is a gap in the record rather than evidence it went unchecked.
See how references were verified.
Links previously used in the corpus¶
Before the registry existed this work was also linked 1 other way.
Registry ID ref:a1a8c6fc4e54 · see in the full table