From the Experts Blog - Montrium

Articles from Montrium's Expert Professional Services team!

Organizations that wish to do business and obtain market approval in both the EU and USA must abide by the requirements of Eudralex Annex 11 and FDA 21 CFR Part 11 respectively. In this blog (a section from our popular Part 11 vs Annex 11 whitepaper), we present a standard approach to demonstrating compliance with both these regulatory directives.

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Where do Annex 11 and Part 11 intersect?