Validación del Proceso IQ OQ PQ: Teoría y Práctica Completas
La metodología de validación del proceso IQ OQ PQ, que significa secuencia de Calificación de Instalación (IQ), Calificación Operacional (OQ) y Calificación de Desempeño (PQ)
Archivo histórico de diseño (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.