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.
GMP, OECD TURKAK GLP, ISO13485 QMS Consultancy

QVAC Validation Consulting

Org chart

Teams

Offices