Pharma + lifesciences

Audit-grade water + utilities for regulated lines.

Pharma, lifesciences, and healthcare plants run two parallel water systems (PW + WFI), distillation, storage and recirculation loops, all under continuous USP / EP / IP / JP scrutiny. CatalystOT + X3EDGE Server gives quality, validation, and engineering teams one source of truth, signed at the edge, retained per GxP.

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Pharma + lifesciences · representative deployment

Outcomes

Polling rate: sub-second
Membrane fouling forecast: 14 – 28days ahead
Compliance: 21 CFR · Annex 11 · GAMP 5
Validation export: FDA-ready

What they feel

Common challenges

RO + EDI + UV trains drift detected only on grab-sample analysis
Sanitation cycle attestation lives in operator notebooks
Distribution-loop dead-leg detection is reactive
Validation evidence scattered across PLCs, spreadsheets, and skid OEM portals

What we ship

Solution shape

AI predictive · membrane fouling 14-28 days ahead, EDI scaling, UV lamp end-of-life
Cryptographic per-cycle attestation of sanitation hold-temperature + duration
Dead-leg detection from millisecond flow drop-out
21 CFR Part 11 + Annex 11 + GAMP 5 + ALCOA+ data integrity built into the storage layer

Bring your pharma + lifesciences fleet here.

Working demonstration on your data within five business days.

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