Lab automation and data in regulated environments

The result at the bench, and the record that has to trust it.

A laboratory produces a result: an analyst at the bench, a robot, an instrument. Somewhere else, a regulated record has to trust that result, in a batch record, a certificate of analysis, a qualification file.

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Lonza · purification and lab automation Roche · GxP master data Switzerland
Where a result lives
Benchanalyst or robot
Instrument softwaremethod, raw data
Lab information systemspecification, result
Regulated recordbatch record, certificate
Who

Amir Messadene, founder.

Amir Messadene, founder of Labionexus

My background is the lab bench and GxP data: at Lonza I ran purification and analytical work and automated it, at Roche I was approval manager for GxP master data, the person who signs off supplier qualification records. So I have been on both sides of a reading, the one who produces it and the one who has to trust it in a regulated record.

At the bench, that meant implementing a CE-SDS method to replace gels and automating its sample preparation on a liquid handler.

Biotechnology engineer, HES-SO Valais-Wallis. Switzerland.

Amir on LinkedIn

The field

Lab automation and lab data, in regulated environments.

Laboratories automate: robots, instrument software, interfaces into the laboratory information system. In a regulated environment, each of those pieces is qualified before use, each change is assessed, and the data they produce has to stand in a record that someone is accountable for.

Labionexus works in that space: the automation that produces a result, and the data path that carries it into the record that has to trust it.

EU GMP Annex 11 21 CFR Part 11 GAMP 5
Now

What I am doing at the moment.

At the moment I am working on one question, with the people who automate regulated laboratories and the people who validate them: where do the days go once a lab automates? If that is your work too, I would like to hear how it looks from your side.

Get in touch

Write a few lines, or book a call.

If this is your field too, write a few lines or book a call. I read and answer every message myself.

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Location Switzerland

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