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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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 […]
