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Consulenze e servizi alle aziende
Le seguenti normative sono la base sulla quale vengono effettuate le nostre validazioni:
-21 CFR Part 11:"Electronic Records; Electronic signatures"
-ICH Guidelinesindex
-ICH - Quality Guidelines
-ICH Q9:Quality Risk Management
-PIC/S GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED GXP ENVIRONMENTS
-ISPE-GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
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