01
Validation strategy
A validation approach scoped with the system, so requirements, risks and tests line up before execution starts.
- Validation strategy & planning
- Risk-based scoping
- Requirements traceability
Pharma & Process · GMP validation
GMP validation & qualification · IQ / OQ / PQ · Lyon Automation that was
designed to pass validation.
AutomatX Labs brings automated systems into a validated GMP state — validation strategy, IQ / OQ / PQ, process validation and the documentation behind them. The engineer who builds the system also qualifies it, so validation is designed in rather than bolted on.
01What’s covered
Validation as part of the engineering, not after it.
Experience spans three regulated pharma settings — packaging qualification, injectable fill/finish, and R&D lab automation — including the process validation of a new injectable vaccine line.
02
Qualification — IQ / OQ / PQ
Protocols written and executed on site, from installation to performance qualification.
- IQ / OQ / PQ protocols
- On-site execution
- Qualification reports
03
Process & computerised system validation
Process validation for manufacturing lines and validation of the software that runs automated systems.
- Process validation
- Computerised System Validation (CSV)
- Data integrity
04
Compliance & documentation
Regulatory-compliant technical documentation, plus the machine-safety and electrical review an instrument needs.
- Regulatory technical documentation
- EN 60204-1 · SELV / PELV review
- Waste-handling procedures (e.g. DASRI)
02How it runs
Scoped with the system, signed off right first time.
01
Scope the validation
Map the system — instrument, software, data — and the regulatory expectations it must meet; agree the strategy up front.
02
Write & execute
Draft the protocols, execute IQ / OQ / PQ on site, and handle deviations as part of the engineering work.
03
Report & hand off
Close out with reports and documentation that keep the system in a validated, maintainable state.
03FAQ
Questions, answered.
What do IQ, OQ and PQ cover?
Installation Qualification checks that a system is installed as specified; Operational Qualification that it works across its intended operating ranges; Performance Qualification that it performs consistently in real use. Together they demonstrate the system is fit for GMP use.
What validation projects have you delivered?
Process validation of a new injectable vaccine manufacturing line (≈ €2.7M, led end to end over ~1.5 years, right first time), plus qualification work across packaging and injectable fill/finish, and R&D lab automation — three GMP environments in total.
Do you validate the software, not only the equipment?
Yes. Computerised System Validation (CSV) and data integrity are part of the scope — useful when the same practice also writes the automation software being validated.
Is this only for Hamilton systems?
No. Hamilton VENUS is the lab-automation specialty, but the validation experience covers manufacturing equipment and lines as well — packaging, fill/finish and vaccine production.
Can the documentation be written in French?
Yes — protocols, reports and technical documentation can be delivered in French or English.
Let’s talk about your project.
Tell me what you’re building, what it has to pass, and where it currently breaks. You’ll get an engineer’s read on scope and the seams — not a sales pitch.