Pharmaceutical sector

Industrial AI for pharma — without breaking GMP or 21 CFR Part 11

iLEAN digitizes the pharmaceutical plant without touching the qualified systems: the batch record leaves the paper, vision inspects 100% of the units, cleaning is validated with evidence and the auditor downloads the dossier from the web. Compliance by design — an immutable audit trail, ALCOA+ data integrity and a 21 CFR Part 11 electronic signature on every capture.

13 cases

Hormonal pharma — oral solid and semi-solids

A paperless MBR, cleaning between hormonal products validated by Edge, zero serial mix-ups, an FDA/COFEPRIS evidence pack and the 5 pillars of compliance by design.

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Tell us your case and we will send the estimated ROI for your plant within 48h.

We work on your plant's real data, not ours. Assessment with no commitment.

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