IQ OQ PQ प्रक्रिया सत्यापन: पूर्ण सिद्धांत और व्यवहार
The IQ OQ PQ process validation methodology, standing for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) sequence
डिजाइन हिस्ट्री फाइल (DHF)
A Design History File (DHF) is a comprehensive collection of documents and records that detail the design and development process of a चिकित्सा उपकरण or product, ensuring compliance with regulatory standards. It encompasses all design inputs, outputs, verification and validation activities, and changes made throughout the उत्पाद जीवनचक्र. 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.