CelesiumAI

Laboratory Data Integrity Risk Cl D8c0

Defensibility analysis grounded in FDA Guidance for Industry: Data Integrity and Compliance With Drug CGMP (2018). Every output cites primary authority and ships a reviewer worksheet.

Framework: FDA Guidance for Industry: Data Integrity and Compliance With Drug CGMP (2018)/methodology

Run a scenario

Fact pattern

A finished-dose pharmaceutical manufacturer receives an OOS result (assay 96.2%, specification 98.0–102.0%) on a release-testing batch. The lab QC director must open a Phase I laboratory investigation under 21 CFR 211.192 and the site's data integrity SOP. The engine ingests the LIMS audit trail export, the analyst's original raw chromatographic data file metadata, the instrument calibration log, and the approved test method. It classifies each data element against FDA DI Guidance ALCOA+ attributes (Attributable, Legible, Contemporaneous, Original, Accurate), flags any metadata anomalies (e.g., back-dated injection sequences, deleted raw data files, audit-trail gap >15 min during active analysis), and produces a risk-classified OOS investigation basis panel citing the controlling regulatory passage. The output includes a reviewer worksheet mapping each flag to the specific 21 CFR 211 or Part 11 requirement and a hedged disposition conclusion ('records reviewed are/are not consistent with the ALCOA+ standard; additional explanations have not been excluded') for QA sign-off and potential FDA inspection response.

Demonstration — engine output is analytical work product, not legal, clinical, or financial advice. Every chip ships with primary-authority citations and a reviewer worksheet so a qualified reviewer can verify the reasoning.