التحقق من صحة عملية IQ OQ PQ: النظرية الكاملة والتطبيق العملي
منهجية التحقق من صحة عملية IQ OQ PQ، والتي تعني تسلسل تأهيل التثبيت (IQ)، والتأهيل التشغيلي (OQ)، وتأهيل الأداء (PQ)
ملف تاريخ التصميم (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.