Validazione del Processo IQ OQ PQ: Teoria e Prassi Complete
La metodologia di convalida del processo IQ OQ PQ, acronimo di sequenza Installation Qualification (IQ), Operational Qualification (OQ) e Performance Qualification (PQ)
File storico della progettazione (DHF)
A Design History File (DHF) is a comprehensive collection of documents and records that detail the design and development process of a dispositivo medico or product, ensuring compliance with regulatory standards. It encompasses all design inputs, outputs, verification and validation activities, and changes made throughout the ciclo di vita del prodotto. The DHF serves as a critical reference for maintaining quality assurance and facilitating audits, thereby demonstrating that the product meets both user needs and regulatory requirements.