Currently browsing "Computer System Assurance"
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The 3 Q’s in Computer System Validation: A Comprehensive Guide to IQ, OQ, and PQ
Executive Summary Computer System Validation (CSV) represents one of the most critical regulatory requirements facing FDA-regulated industries today. In an increasingly digital landscape where pharmaceutical manufacturing, clinical trials, and medical device development rely heavily on computerized systems, the stakes for proper validation have never been higher. At the heart of CSV lies the qualification process—specifically […]
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Understanding FDA Software Validation
In the dynamic landscape of healthcare technology, the development and deployment of software play a crucial role in patient care, diagnostics, and overall healthcare management. However, with innovation comes the need for stringent regulations to ensure the safety and effectiveness of medical software. The Food and Drug Administration (FDA) plays a pivotal role in overseeing […]
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9 Tips To Comply with 21 CFR Part 11
For highly regulated medical device organizations and life science industries, it has become a challenge to achieve 21 CFR Part 11 compliance and a matter of concern for companies subject to FDA inspections. Organizations must follow best practices in maintaining compliance and the quality process by following the 21 CFR Part 11 regulation. However, as […]
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FDA Transition to Computer System Assurance: The New CSV
The 2003 FDA guidance paved the road for the implementation of efficient computer system validation for the pharmaceutical industry. Following that FDA guideline, the life science industry has become more efficient in validating computer systems and documentation in order to comply with regulations, inspections, compliance, and audits. The FDA launched the Case for Quality in […]
