Pier Luigi Agazzi

Computerized System validation assessment and remedial plan of the whole plant – Medical Devices; Implantable

Automation Engineering and Validation of a new Sterile Filling and Liophylization plant - Novartis - Stein AG

Computer Systema Validation consultancy: Supplier Audits Validation of an ERP (SAP) System. Validation of a new LIMS system (from SQL LIMS to Labware) Validation of a Chromatographyc Data Management System (Empower) Validation of a Farmacovigilance system (Oracle Clinical)

Computer System Validation consultant Periodic audit of the Information Technology Group. Validation of a Documentation and Training database management system. Validation of an Environmental Monitoring System. Complete 21 CFR Part 11 compliance assessment of a new plant (including Labs)

Computer System Validation Consultant Validation of an ERP (SAP) System including supplier audit. Validation of an electronic management system for dispensing. Validation of a Chromatographic data management system (Chromeleon) Validation of a data management system of Biological trends Complete 21 CFR Part 11 compliance assessment, and remedial plan of the whole plant (including Labs).

Automation Engineering New Sterile Filling and Liophylization plant (Process Automation).