Information Technology & Services - , Istanbul, Turkey
GMP, OECD TURKAK GLP, ISO13485 QMS Consultancy.Computerized System Validation, Software validation, Digitalization & Serialization, MES, ERP validation and Medical Device Cyber Security .Laboratory, Production & Utility services Equipment Qualification; Installation & Operational and Performance Qualification studies as a risk based approach.AI medical device software validation, engineering project management.Providing MHRA data integrity Gap analysis and applications. Basen on 21 CFR Part 11, ISO 62304, ISO80002, FDA, PIC/S, PDA, EU Annex regulations.
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