IQ OQ PQ प्रक्रिया सत्यापन: पूर्ण सिद्धांत और व्यवहार
IQ OQ PQ प्रक्रिया सत्यापन पद्धति, जो इंस्टॉलेशन क्वालिफिकेशन (IQ), ऑपरेटशनल क्वालिफिकेशन (OQ), और परफॉर्मेंस क्वालिफिकेशन (PQ) क्रम का प्रतिनिधित्व करती है।
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 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.