ENIT
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ENIT

Industries · Pharmaceutical

Every batch documented.Every parameter under control.

Pharmaceutical production combines complex formulations, connected devices, cleanrooms and strict documentation. Metalya manages recipes, controls critical parameters in real time and traces every component — producing the records audits ask for.

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  1. 01Dispensing
  2. 02Formulation
  3. 03Processing & sterilisation
  4. 04In-process control
  5. 05Packaging & QA release

The context

What makes it difficult.

Formulations change with demand and regulation; devices and autoclaves must receive exactly the approved parameters; laboratory results, calibrations and every action must be recorded and traceable for European (EMA, GMP) and US (FDA, 21 CFR) audits.

  • 01

    Complex formulations

    Recipes must adapt to demand and regulatory specifications without losing control of versions.

  • 02

    Parameters to devices

    Production devices and autoclaves must receive approved parameters, with secure, bidirectional communication.

  • 03

    Deviations caught late

    A process deviation discovered after the batch means non-conforming product.

  • 04

    Documentation for audits

    Batch records, test results and process evidence are compiled by hand for each inspection.

How Metalya helps

The capabilities that matter here.

MOMRecipes and formulationsCentrally managed recipes and formulations, dispatched as parameters to the specific devices that run them.QualityCritical parameters in real timeProcessing parameters monitored continuously, with immediate response to deviations from limits.Materials & TraceabilityUnique identificationBarcode and RFID identification of components and lots, with genealogy from raw material to finished batch.QualityLaboratory quality controlTest results recorded automatically for each batch; instruments under calibration management.MOMSterilisation and cleanroomsSterilisation steps — from devices to autoclave cycles — and cleanroom activities documented step by step.MOMTraceable actionsEvery action recorded through computerised procedures with controlled, traceable access.QualityValidation and regulatory supportProcess validation with detailed documentation, designed to support GMP (EU) and 21 CFR (US) requirements and the digital records audits need.

Adapted with Studio

Experiences shaped for this floor.

Examples of screens and workflows teams compose on the core — without changing it.

  • A line-clearance checklist that must be completed before a batch can start
  • A batch review screen for QA with results, deviations and documents in one place
  • A cleanroom terminal showing the active recipe, sterilisation status and pending checks

Architecture

ERP & business systemsMetalya Core · APS · StudioMachines, PLC & equipment

See Metalya on a pharmaceutical scenario.

Bring your routings and constraints; we will show them running on the core and adapted for your teams.

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