
IQ OQ PQ Process Validation: Full Theory & Praxis
The IQ OQ PQ process validation methodology, standing for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) sequence
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.
The IQ OQ PQ process validation methodology, standing for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) sequence
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