Qualification & validation (CQV / CSV)
Compliant equipment, utilities and computerised systems, with a file that stands up to inspection.
Putting equipment into service in a GMP environment means proving, with documents, that it does what it was designed to do and will keep doing it.
POMEX supports the qualification of equipment, utilities and computerised systems, from the validation plan to the final report. We work with production sites in Wallonia (Hainaut, Walloon Brabant, Namur, Liège), Brussels and northern France.
What we do
Our consultants cover the whole qualification and validation cycle:
- writing and reviewing validation master plans (VMP), risk assessments and traceability matrices;
- DQ, IQ, OQ and PQ protocols and execution, deviation management and summary reports;
- computerised system validation (CSV) according to GAMP 5 and Annex 11: specifications, testing, data integrity;
- periodic requalification and maintaining the validated state after changes (change control).
Our added value
Our consultants know the field: they have qualified filling lines, critical utilities and control systems. They speak the language of both technical teams and quality assurance, which shortens review cycles.
How we work
We adapt our support to your project:
- reinforcing a project team for a defined period;
- leading a qualification package, with commitment on deliverables;
- one-off support before an inspection or audit.
The expected result
A complete, clear validation file that stands up to inspection, delivered on the project schedule.