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

Alpay ÇALIŞKAN

This department ensures that products and services meet quality standards and regulatory requirements through validation processes.

Quality Assurance

This department focuses on ensuring the integrity and compliance of processes through validation activities.

QVAC Validation Consulting

Org chart

Teams

Quality Assurance

Validation Services

Offices

QVAC Validation Consulting

Org chart

Teams

Quality Assurance

Validation Services

Offices

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