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Filipa d’Orey

filipadorey

Business Unit Director at Scal

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Medical device manufacturing May 29, 2025
How MES Enhances Manufacturing Efficiency and Quality while Complying with FDA 21 CFR Part 11 Requirements

In the highly regulated world of industrial manufacturing, compliance with stringent regulatory standards is not just a recommendation – it’s a necessity. One of the most important regulations for companies that maintain records or submit information electronically in the pharmaceutical, medical device, and other regulated industries is FDA’s 21 CFR Part 11.