Learning Management & Talent Development Insights
For 20 years, eLeaP® has helped organizations achieve excellence through learning, performance, & quality.
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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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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 […]
