Learning Management & Talent Development Insights
For 20 years, eLeaP® has helped organizations achieve excellence through learning, performance, & quality.
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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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The 3 Q’s in Computer System Validation – IQ OQ PQ
Adopting a Computer Systems Validation approach for the various systems companies use is easier said than done when it comes to FDA-regulated organizations. Managing the computer system validation process is often comprehensive, with many steps from beginning to completion. Even one failure in the process can lead to devastating consequences for patients and the organization, […]