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On August 20 of 1997, the United States Food and Drug Administration (FDA) issued a document known as Rule 21 CFR Part 11. This was requested and developed with input from the pharmaceutical industry and outlines the FDA criteria for accepting electronic records and signatures. All companies and industries who submit or utilize electronic records and/or signatures regulated by the FDA must comply with this federal regulation. This document explains how Thermo’s Xcalibur data system can help you achieve 21 CFR Part 11 compliance. |
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