Pays d'origine: Italie
Norme de certification: Méthodologie de qualification conforme aux exigences réglementaires GxP, aux Bonnes Pratiques de Fabrication (cGMP) et à la validation des systèmes informatisés (CSV)
Application: Étalonnage des instruments, élaboration du Plan Directeur de Validation/Plan de Qualification, exécution DQ/IOQ/PQ, validation des systèmes informatisés et validation du nettoyage pour les sites pharmaceutiques réglementés

Autres informations

Description supplémentaire:

Qualification services cover instrument calibration; drafting of Validation Master Plans and Qualification Plans; execution of DQ, IOQ, PQ and periodic qualification; computer system validation; cleaning validation; data integrity assessments; GxP, regulatory and EHS risk analysis; and SOP development with associated training. For larger strategic projects, dedicated resources can be supplied, including a C&Q Coordinator/Validation Manager, QA Specialist/Deviation and Change Control Manager, Technology Transfer Specialist, and Supplier Auditor.