FDA-compliant shop floor, with AI-powered Leucine MES.

A traditional MES is a system of record: it digitises paper, enforces the workflow, and tells you what happened. An AI-native MES reasons over that same data and acts on it: Cortex agents detect deviations as they occur, predict yield, and resequence schedules, so reviewers work by exception instead of checking every line. Record-keeping is identical and just as compliant; the difference is that the system works the data for you, with every agent action running through your approval workflows and a full 21 CFR Part 11 audit trail.

No. Cortex agents advise; humans decide. Every recommendation, whether a flagged deviation, a yield adjustment, or a schedule change, flows through your existing approval workflows, and nothing is committed without an authorised electronic signature. Every agent action traces back to the source record with a full 21 CFR Part 11 audit trail.

Cortex runs inside the same validated, controlled environment as the rest of the platform. Models are qualified against defined acceptance criteria before release, their performance is monitored continuously in production, and any model update runs through formal change control with regression evidence, so your validated state is never silently altered. Agents also never write to the record on their own: every recommendation is an input to your existing approval workflow, committed only on an authorised electronic signature and traced end to end in the 21 CFR Part 11 audit trail. You validate the controls around the agents and the human decision points, not a black box.

Most sites go live in 8–12 weeks. Leucine MES ships with pre-configured templates for common pharma workflows like batch execution, material dispensing, and electronic logbooks, so implementation is configuration, not custom development. Cipla deployed across 30 facilities; Piramal went live across 10+ sites spanning FDA, MHRA, and EMA jurisdictions.

You migrate in phases, running both systems in parallel, with no big-bang cutover. Leucine MES models your products, equipment, and processes in a single unified data model (ontology), so Master Batch Records are re-authored from configurable templates rather than rebuilt from scratch, and historical batch data can be imported where it adds analytical value. Most sites start with one product line or logbook, prove equivalence, then expand: the same phased approach Piramal used across 10+ sites and Cipla across 30 facilities.

You keep them and move forward cleanly. Leucine MES starts with electronic logbooks and digital batch records going forward, while legacy paper stays archived and referenceable; historical data can be imported into the ontology where it adds value. Most sites begin with production logbooks, where compliance risk is highest, and expand from there.

Adoption is faster than most teams expect because execution is guided: operators follow on-screen steps, scan instead of transcribe, and the system blocks errors at the point of entry rather than at review. Role-based screens mean each user sees only their own tasks. Cipla credentialed 8,000+ staff across 30 facilities on the platform, and the logbooks-first rollout eases change management by starting with the simplest workflows before batch records. Explore MES training and certification.

Fully compliant. Every action is backed by electronic signatures with identity verification, immutable audit trails, role-based access, and configurable approval workflows, meeting 21 CFR Part 11 and EU Annex 11. The platform is deployed in facilities inspected by FDA, MHRA, and EMA, including Piramal’s multi-jurisdiction operations. See how MES prevents FDA 483 observations.

Yes. Leucine MES is delivered with a full computer-system-validation package: GAMP 5 categorised, with IQ, OQ, and PQ protocols, requirement traceability, and validation summary reports your QA and IT teams can execute and audit. The platform runs on SOC 2 Type II infrastructure, so security and availability controls are independently attested.

Your validated state is preserved across updates. Each platform release ships with updated validation documentation and regression evidence, and your site-specific configuration carries forward untouched, so updates run through your existing change-control process with risk-based re-validation of only what changed, not a full re-validation every time. The underlying SOC 2 Type II infrastructure is independently attested on an ongoing basis.

Leucine MES is cloud-native, delivered on enterprise Azure infrastructure with SOC 2 Type II controls. Data-residency options let you keep records in a specific region to meet local data-sovereignty and regulatory requirements, and each site’s data stays logically isolated and role-scoped. On-site L2 edge gateways handle shop-floor connectivity locally, so equipment data is captured at the source and synced to the cloud.

Master Batch Records are authored centrally and deployed per site with locale-specific overrides, while each site’s execution data stays logically isolated and role-scoped. Data-residency options let you pin records to a specific Azure region (for example the EU, US, or India) to meet local regulatory and data-sovereignty requirements, with encryption in transit and at rest.

Your records are yours, and you can take them with you. Every batch record exports as an audit-ready PDF, and structured data (batch records, logbooks, audit trails, and master data) exports through open APIs and standard formats such as CSV and JSON. There is no proprietary lock-in on your GxP records: you keep full, inspection-ready copies for your retention requirements whether or not you stay on the platform.

No data is lost and no record is corrupted. On-site edge gateways capture and buffer equipment and process readings locally, then reconcile to the cloud once connectivity returns, so a network drop never creates a gap in the batch record. The platform runs on redundant infrastructure with a 99.9% uptime SLA, and every entry is written to an immutable, time-stamped audit trail. An interruption is recoverable and fully traceable, not a data-integrity event.

Yes. Leucine MES connects with SAP, Oracle, and other ERP systems to receive production orders and return batch completion data. The L2 integration layer also supports direct shop-floor connectivity (OPC-UA, Modbus TCP, MQTT, PI/Historian) through pre-built edge gateway connectors and an Azure cloud pipeline.

SCADA and historian systems connect through the L2 integration layer: OPC-UA, Modbus TCP, MQTT, and PI/Historian connectors bring process parameters straight into batch records. LIMS, QMS, and other GxP systems connect through open REST and SOAP APIs to exchange specifications, results, and quality events, and quality workflows can also run natively on LeucineOS rather than through a separate system. Connectivity is pre-built or API-driven, with no custom middleware project.

Pricing scales with adoption: Leucine MES is a single enterprise subscription, licensed by the products you actively manufacture, with unlimited users and batch executions. Because most sites start with logbooks and expand into batch records, you pay as you roll out rather than all on day one. The exact figure depends on your number of sites, the modules you deploy, and scope of use, and we scope a quote to your footprint on a walkthrough.