PHARMA & BIOTECH SECTOR

MES for the pharmaceutical and biotech industry

In a regulated environment, a documentation error carries the same weight as a manufacturing error.

QPlant helps pharmaceutical plants manufacture with documentary rigor: a digital process guide, an EBR connected to the MES, deviation management and full batch traceability. Less paper, faster batch review and compliance evidence available for any audit.

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pharmaceutical industry

The Pharmaceutical and Biotech Industry

Pharmaceutical and biotech plants don’t just have to manufacture well: they have to prove it. Every batch is a file that can be reviewed by a regulator, a customer or an auditor. Review is slow because documentation is scattered, and deviations are managed late because manufacturing and quality don’t talk to each other.

QPlant brings documentary rigor: a digital process guide, an EBR connected to the MES and real-time deviation management, integrating with your systems (ERP, LIMS, SCADA) for seamless digitalization.

The challenges of Pharma & Biotech

Pharmaceutical and biotech plants don’t just have to manufacture well — they have to be able to prove they manufactured well. Every batch is a file that someone can review: a regulator, a customer, an internal quality auditor. Batch review takes time because documentation is scattered. Deviations are managed late because the manufacturing and quality systems don’t talk to each other. And the EBR exists on paper or on sheets that someone fills in by hand.

Batch review and EBR

Batch review and EBR

  • Electronic Batch Record connected to the MES
  • Materials, operations, parameters and controls in a single record
  • Deviations, signatures and evidence included
  • Review on the automatically generated EBR
  • No manual collection of documents
Deviation management (OOS)

Deviation management (OOS)

  • Mandatory controls in the process guide
  • Automatic alerts on deviation
  • Automatic batch blocking
  • Record with digital signature
  • Managed in the moment, not at shift close
Critical process parameters

Critical process parameters

  • Monitoring from SCADA and connected equipment
  • Automatic alert for out-of-range values
  • Values timestamped and traced in the EBR
  • Evidence of process within specification
  • Verifiable by any auditor
FDA, EMA or AEMPS audits

FDA, EMA or AEMPS audits

  • Bidirectional traceability
  • Accessible electronic Batch Records
  • Quality records available in the system
  • Verifiable documentation
  • Auditing as verification, not as a search
Yield and high-value materials

Yield and high-value materials

  • Warehouse integrated with production and traceability
  • Every consumption recorded against order and batch
  • Real yield visible by batch and line
  • Detection and investigation of material losses
  • Control of actual consumption
BENEFITS

What your plant gains

Every challenge solved with QPlant translates into a concrete, measurable improvement in your operation.

Reto: Slow batch review · Solución: EBR connected to the MES, everything in a single record

Batch review is done on the EBR generated automatically during manufacturing, not by collecting documents.

Reto: Late deviations (OOS) · Solución: Quality in the process guide: alerts and batch blocking

Deviations are managed in the moment, not at the end of the shift, and are documented with no extra work.

Reto: Critical parameters without evidence · Solución: Monitoring from SCADA integrated into the EBR

Any auditor can see that the process ran within specification, with timestamped and traced data.

Reto: FDA / EMA / AEMPS audits · Solución: Batch Records and bidirectional traceability

The documentation exists and is verifiable. The audit becomes a verification, not a search.

Reto: High-value materials without control · Solución: Warehouse: consumption recorded by order and batch

Real yield is visible by batch and by line. Material losses are detected and can be investigated.

QPLANT SUITE

Priority modules for Pharma & Biotech

The QPlant modules that deliver the most value in this sector. They can be deployed together or in phases.

PRODUCTION

QPlant Production

Captures actual execution, calculates OEE and records production, rejects, scrap and downtime.

Quality

QPlant Quality

Controls, inspections, SPC and non-conformities integrated into the process, with evidence for auditing

Traceability

QPlant Traceability

Batch-to-batch traceability backward and forward, ready for audit and recall.

Warehouse

QPlant Warehouse

Locations, quality statuses, FEFO/FIFO, picking and real-time stock.

Analytics

QPlant Analytics

Dashboards for OEE, quality, scrap and performance, with loss analysis and AI.

Planner

QPlant Planner

Finite capacity planning with scenario simulation and changeover optimization.

MAINTENANCE

QPlant Maintenance

CMMS connected to production: work orders, preventive, predictive and KPIs.

TIME ATTENDANCE

QPlant Time Attendance

Presence, shifts, access control and time allocation, connected to shop floor operations.

Solutions

Solutions and products for the Pharmaceutical Industry

TAI offers a suite of integrated products under the MOM/MES QPlant platform, designed to meet the challenges of the pharmaceutical industry.

Pharmaceutical Industry References

Companies in the pharmaceutical sector that have trusted our solutions.

Reseñas

Lo que dicen nuestros clientes

Empresas de distintos sectores han confiado en nosotros para resolver sus desafíos. Descubre cómo impactamos positivamente sus resultados.