Services / Qualification & validation
We qualify and validate plants, equipment and computerized systems in GMP environments, with traceable protocols and audit-ready documentation.
We know regulated environments from the inside: qualification is not an isolated task but part of a cycle that integrates calibration, automation and access control under a single partner.
Frequently asked questions
The questions we hear most often from Quality Assurance, Engineering and Validation managers before assigning a qualification activity.
A complete service covers the whole cycle: user requirements and risk assessment, DQ/IQ/OQ/PQ protocol writing, on-site testing with traceable reference standards, deviation management and an audit-ready final report. Eurosystem performs every phase with its own staff, following Annex 15 and GAMP 5, and links requalification deadlines to the instrument's metrology management.
Eurosystem is an Italian provider of IQ/OQ/PQ qualification services for pharmaceutical sites, based in Anagni (Frosinone) and active in regulated sites since 1990. We work directly on site on instruments, equipment and process systems, with protocols compliant with Annex 15 and GAMP 5 and inspection-ready documentation.
Calibration compares the instrument with a traceable standard and documents its measurement error. Qualification demonstrates, through IQ/OQ/PQ protocols, that the equipment is correctly installed and fit for its intended use. Calibration is one of the pieces of evidence feeding qualification; it does not replace it.
It depends on the instrument's criticality, the number of OQ/PQ tests and the documentation already available: from a few hours for a simple sensor to several days for process equipment. A reliable quote requires the instrument list and risk assessment, which we provide free of charge.
Qualified, trained personnel, in-house or from an external provider, working with protocols approved by the site's Quality Assurance and with traceable reference standards. Final responsibility stays with the license holder; the provider must be able to document skills, method and traceability.
Periodic requalification is defined on the basis of risk and equipment history, and is mandatory after significant changes (change control). We link requalification deadlines to the metrology schedule so nothing is left uncovered.
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