Automation • Integration • Compliance

Instrument‑to‑LIMS integration projects for Swiss mid‑pharma and CDMOs. CSV‑validated.

Labionexus connects your lab equipment to your existing LIMS, CSV‑validated, in weeks not months. Built for mid‑pharma and CDMOs with LabWare, Veeva, STARLIMS, Empower or equivalent already deployed.

HPLC
pH-meters
Balances
LIMS
ELN
MES
Instruments Labionexus Systems

Faster

Reporting cycles

Traceable

End-to-end data integrity

GAMP5

Cat 4 validated

24h

Response time

Ex‑Lonza, ex‑Roche engineer

GAMP 5 Cat 4 Configured Product

Co‑delivered with certified CSV partners

Built in Switzerland

Who we are

About
Labionexus

Labionexus delivers instrument‑to‑LIMS integration projects for Swiss mid‑pharma and CDMOs, co‑delivered with certified CSV partners.

Founded by Amir Messadene, biotechnology engineer (HES‑SO Valais‑Wallis) with hands‑on experience in microbial downstream purification at Lonza and GMP data integrity at Roche.

We focus on simplicity, compliance, and interoperability, enabling labs to evolve into fully connected, data‑driven environments.

Connect with Amir on LinkedIn
Biotech expertise Lab automation GxP compliance Data integration

What we offer

End-to-end lab integration

From instrument connectivity to regulatory compliance, we deliver solutions that transform how your lab operates.

Instrument Integration

HPLC (Empower, ChemStation), pH‑meters, balances (Mettler Toledo, Sartorius), Karl Fischer titrators (Mettler Toledo, Metrohm), TOC, osmometers, Solo VPE, Raman, FTIR, UV/Vis, NIR, Endoscan‑V, and climate sensors.

Workflow Automation

Reduce manual steps with scripted automation and scheduling. Improve reproducibility via API‑based integration.

Regulatory Compliance

  • • 21 CFR Part 11 (FDA: electronic records)
  • • EU GMP Annex 11 (computerised systems)
  • • GAMP5 2nd Ed. Cat 4 (configured products)
  • • ICH Q10 (pharmaceutical quality system)
  • • ALCOA+ principles (data integrity)

Advanced Reporting

Centralize process data into interactive dashboards for real‑time insights in R&D and QA.

Compatibility

Supported instruments

We connect a broad range of lab instruments to your LIMS, regardless of vendor or protocol.

HPLC / UHPLC

Waters Empower, Agilent ChemStation

pH-meters

Mettler Toledo, Hanna Instruments

Spectroscopy

Raman, FTIR, UV/Vis, NIR

TOC Analyzer

Multiple vendors supported

Osmometer

Vapor pressure & freezing point

Solo VPE

Variable pathlength spectroscopy

Microbiology

Endoscan-V (Endosafe / Charles River)

Balances

Mettler Toledo, Sartorius

Karl Fischer

Mettler Toledo, Metrohm — moisture content

Climate / Environmental

Temperature, RH, pressure sensors

Validation approach

Qualification framework

GAMP5 Category 4: Configured Product

The Labionexus platform is validated as a GAMP5 Category 4 Configured Product. The standard layer is qualified by Labionexus with full vendor documentation, ensuring a robust and auditable foundation.

Site-specific IQ/OQ/PQ qualification

Each client deployment includes a site-specific configurable layer with User Requirements Specification (URS), Risk Assessment (RA), Requirements Traceability Matrix (RTM), and full IQ/OQ/PQ protocols tailored to your environment.

Vendor Qualification Package (VQP)

Every deployment includes a complete Vendor Qualification Package for your quality records. Each deployment includes IQ/OQ/PQ qualification delivered with our CSV partner network.

EU GMP Annex 11 21 CFR Part 11 GAMP5 2nd Ed. ALCOA+ ICH Q10

Real impact

Measurable results for your lab

See how our integration solutions deliver tangible improvements across lab operations.

Faster reporting

Reporting Time

Reduce reporting time with automated capture and pre‑formatted outputs. No more manual copy‑paste between systems.

Full traceability

Data Integrity

Eliminate manual transfer errors and ensure full traceability with automated audit trails at every step.

Connected systems

Interoperability

Connect your LIMS, ELN, and MES with your instruments through one validated integration project.

Get in touch

Discuss your integration project

Get in touch to discuss your instrument scope, LIMS environment, and CSV requirements. We respond within 24 hours.

Prefer a live conversation?

Book a 20-min discovery call directly.

Book a discovery call

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Location

Switzerland

Response time

Within 24 hours

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