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 — Guidance for Industry.

Type

Report

Intellectual base

Grey literature

Year

2018

Link

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers-guidance-industry

Cited from

philosophy

Cited by

1 citation across 1 artifact.

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.

Verification

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