GxP, 21 CFR Part 11, electronic batch records, end-to-end lot genealogy. Built so quality, compliance and operations can finally use the same system without anyone losing trust in the data.
Why pharma plants pick MOSES
Pharma operations are uniquely caught between two pressures. Regulators want more rigour every year — DSCSA, EU FMD, Annex 11, data integrity guidance. Internally, plant heads want the same things every plant head wants: more yield, less downtime, faster batch release.
MOSES sits between the MES and the floor — replacing the paper bridge that connects them. Batch records become electronic by default. Deviations are tracked at the source. CAPA workflows route themselves. The audit trail isn't generated at audit time — it's just what the system does.
Pharma-specific capabilities
Out of the box, every pharma deployment ships with these modules pre-configured to the regulatory model.
- Electronic Batch Records (EBR) — every operator action, every parameter, every deviation captured with electronic signature.
- Lot & genealogy tracking — full pedigree from raw material receipt to finished pallet, queryable by lot, batch, or serial.
- Deviation & CAPA workflows — pre-built RCA templates (5-why, fishbone, 8D). Effectiveness verification baked in.
- Environmental monitoring — connect particle counters, T/RH probes, differential pressure sensors directly into the operational data fabric.
- Cleaning & changeover validation — enforce the right SOP version, capture before/after photos, sign-off chains.
- Training & qualification — operators can't start a task they're not currently qualified for. Versioned training records.
Compliance, by construction
We don't sell "compliance features." We build the platform so compliance is what happens by default.
Every record is immutable and append-only. Every change is signed. Every report is reproducible from the underlying event log. Deployments run fully on-prem with zero outbound connectivity, customer-owned encryption keys, and signed update bundles.
We have not failed a customer audit on data integrity grounds since 2023. We don't expect to.— MOSES quality engineering
How a pharma deployment looks
Pharma plants don't deploy software like SaaS companies. We don't pretend otherwise. The typical sequence:
- Validation kickoff with QA — URS, FRS, configuration spec frozen.
- Read-only edge gateway installation. No PLC firmware changes, ever.
- One module live for one line in shadow mode for two weeks.
- OQ/PQ executed with our team alongside yours.
- Cutover with paper running in parallel for one batch cycle.
- Paper retired. Operators on tablets. CAPA loop closes in hours instead of weeks.
See what your pharma plant looks like on MOSES.
A working demo with mock data is one click away. A real one — with your data — is one conversation away.