1. Concept
2. Project
3. Operation
4. Retirement
La nostra esperienza nella convalida è forte di una approfondita conoscenza dei processi GxP e dei relativi sistemi quali:
- IT Business Systems (e.g., ERP, LIMS, MES),
- Pharmacovigilance Systems (e.g. ARGUS,
AERS, SafetyDrugs, Veeva Safety) - Laboratory Systems (CDMS, HPLC, GC,
HPLC, GC, UV VIS, Difrattometro, Bilance,
Microbiological equipment)
- Manufacturing Systems (e.g PLC, SCADA, Equipment, eBRS, Dispensing Systems)
- Clinical Applications (e.g. Oracle Clinical, DataTrak One, Veeva Vault CDMS, Veeva eTMF, Custom eCRF)
I nostri servizi in ambito CSV coprono tutte le fasi del ciclo di vita di un sistema:
- Definizione Policy and SOPs sui processi di computer system validation
- Vendors Selection and Qualification
- Computer System Validation Strategy
- GxP Risk Assessment
- Process Mapping & definizione User Requirements
- Revisione documentazione tecnica dei fornitori
- Design Review
- Test strategy definition and execution
- Validation Reporting
- Data Migration Strategy and Execution
- Change Management
- Periodic Compliance Review
- Business Continuity & Disaster Recovery
- Computer Inspection Readiness Support
- Infrastructure Qualification
- Decommission Planning and Reporting
- Data Archiving
