IQ OQ PQ 프로세스 검증: 완벽한 이론과 실제
The IQ OQ PQ process validation methodology, standing for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) sequence
설계 이력 파일(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.