
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)
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, verifica E convalida 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.
La metodologia di convalida del processo IQ OQ PQ, acronimo di sequenza Installation Qualification (IQ), Operational Qualification (OQ) e Performance Qualification (PQ)
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