The whitepaper explains how machine vision technology aids pharmaceutical and medical device companies in ensuring quality control, track-and-trace capabilities, and compliance with 21 CFR Part 11 regulations. These systems, including barcode reading and deep learning, are vital for automation, especially with the increased demand from COVID-19 for automated manufacturing of test kits and vaccines. Key compliance aspects include system validation, record accuracy, and audit trails. The paper also notes that the EU’s Annex 11 parallels the U.S. Part 11 regulations, ensuring global alignment for electronic record management in manufacturing.

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