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 medical device or product, ensuring compliance with regulatory standards. It encompasses all design inputs, outputs, verification and validation activities, and changes made throughout the product lifecycle. 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.