The standalone instruments your analysts still read and retype, balances, pH meters, titrators, produce a record that is not controlled at the moment it is created, which is what makes a later change both possible and undetectable. It is also why a second person has to check every number. We capture each reading at the source and sign it on the gateway at the point of capture. The route into your LIMS or ELN is a connector scoped to your system, built with you. The signing key is generated on the gateway and never transmitted, and no interface we ship can export it, so a valid signature can only have been produced by that gateway's own key. Your auditor re-verifies the record against the device public key with no secret of ours involved, and your QA qualifies it with the CSV resource you already use. The device signature binds the record to the gateway that captured it, not to a person: signatures by your people stay in the system where you sign today, under your own Part 11 or Annex 11 controls. Built for regulated labs in Swiss mid-pharma, biotech and CDMOs.
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From capture to a verifiable record, delivered as one scoped project.
Each instrument is scoped with you before anything is built. Balances, pH meters, titrators, TOC analyzers, spectrometers and climate sensors are typical examples rather than a boundary: what decides is whether someone still retypes the number. Capture is read-only, so the instrument is not driven, reconfigured or updated. Chromatography is usually already integrated, so we bridge it only if you want one record across the whole bench.
Reduce manual steps with scripted automation and scheduling. Improve reproducibility through API-based integration.
Every captured result stays queryable and independently re-verifiable. A record for your quality file, not just a dashboard. Ask any supplier for one reading signed on the device that captured it, at the moment of capture, plus the public key of that device, then see whether you can check it yourself with nothing of theirs installed. Ask us the same, and we will run that check with you.
We do not start from a list of instruments. We start from a reading a person still copies into your record, and from one constraint: capturing it must not change how your instrument is qualified. Everything below follows from those two.
Balances, pH meters, Karl Fischer titrators, and most benchtop instruments that already print what they measure. The instrument is not driven, reconfigured or updated, so its qualified state is untouched.
Fridges, incubators, stability chambers, differential pressure gauges on an airlock. The clipboard on the door is a GxP record, created the same way as any other number a person copies by hand.
Spectroscopy (Raman, FTIR, UV/Vis, NIR), TOC analyzers, osmometers, variable pathlength, Endoscan-V. We take the export the instrument already produces.
Chromatography such as Empower or ChemStation, and anything already recorded automatically by a validated system. There is nothing here for us to fix, and we will tell you so. We bridge it only if you want one record across the whole bench.
Chromatography is usually already integrated. The readings that still travel by hand are the gap. The vendor names above are examples, not a compatibility list. What puts an instrument in scope is whether a person is currently in the loop, not what the instrument is called. Nothing here is a pre-built connector you switch on: each instrument is scoped with you first, and the qualification documentation is scoped per instrument so your QA qualifies against intended use.
Not sure which of your readings qualify? That is the first thing we work out together.
A standard layer documented for GAMP 5 assessment, plus the site-specific documentation your QA needs to qualify against intended use.
The Labionexus platform is built and documented to support a GAMP 5 assessment. We provide full vendor documentation so your team completes the risk-based categorization and qualification against intended use.
Each deployment is scoped to include a site-specific configurable layer with User Requirements Specification, Risk Assessment, Requirements Traceability Matrix and full IQ/OQ/PQ protocols tailored to your environment.
Each deployment is scoped to ship with a complete Vendor Qualification Package for your quality records, with IQ/OQ/PQ protocols ready for execution by your QA or the CSV resource you already use.
Labionexus delivers instrument-to-LIMS integration for Swiss mid-pharma and CDMOs, with the qualification documentation your QA needs.
Founded by Amir Messadene, biotechnology engineer (HES-SO Valais-Wallis) with hands-on GMP data integrity experience at Roche and microbial downstream purification at Lonza.
We focus on simplicity, compliance and interoperability, helping labs evolve into fully connected, data-driven environments.
Tell us your instrument scope, LIMS environment and CSV requirements. We reply within one business day.